Acetaminophen (paracetamol), a para-aminophenol derivative, has analgesic and antipyretic properties and weak anti-inflammatory activity. The purpose of the present study was to evaluate the bioequivalence of two acetaminophen tablets, $Tylenol^{\circledR}$ ER (Janssen Korea Ltd.) and Tylicol ER (Hana Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of acetaminophen from the two acetaminophen formulations in vitro was tested using KP VIll Apparatus II method with pH 1.2 buffer solution. Twenty six healthy male subjects, $22.8{\pm}1.99$ years in age and $65.6{\pm}8.03$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 650 mg as acetaminophen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of acetaminophen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in pH 1.2 buffer solution. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Tylenol^{\circledR}$ ER, were 2.84, 1.89 and -1.36% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log $0.987{\sim}log$ 1.08 and log $0.944{\sim}log$ 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Tylicol ER tablet was bioequivalent to $Tylenol^{\circledR}$ ER tablet.
Finasteride $[N-(1, 1-dimethylethyl)-3-oxo-4-aza-5{\alpha}-androst-1-ene-17{\beta}-carboxamide]$ is a 4-aza-3-oxosteroidal inhibitor of human $5{\alpha}-reductase$. The purpose of the present study was to evaluate the bioequivalence of two finasteride tablets, $Proscar^{\circledR}$ (MSD Korea Ltd.) and Procare (Hana Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of finasteride from the two finasteride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $23.7\;{\pm}\;2.24$ years in age and $67.2\;{\pm}\;8.55\;kg$ in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After two tablets containing 5 mg as finasteride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of finasteride in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t,\;C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Proscar^{\circledR}$, were 6.39, 4.65 and -13.9% for $AUC_t,\;C_{max},\;and\;T_{max},$ respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.800 to log 1.25 $(e.g.,\;log\;0.990{\sim}log\;1.14\;and\;log\;0.977{\sim}log\;1.13 for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procare tablet was bioequivalent to $Proscar^{\circledR}$ tablet.
Lornoxicam is a nonsteroidal anti-inflammatory drug that decreases prostaglandin synthesis by inhibiting cyclooxygenase. It has analgesic, antipyretic and antiinflammatory effects. The purpose of the present study was to evaluate the bioequivalence of two lornoxicam tablets, $Xefo^{\circledR}$ (Hyundai Pharmaceutical Ind. Co., Ltd.) and Lornocam (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of lornoxicam from the two lornoxicam formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, $24.39{\pm}1.95$ years in age and $68.63{\pm}7.25$ kg in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After a single tablet containing 4 mg as lornoxicam was orally administered, blood samples were taken at predetermined time intervals and the concentrations of lornoxicam in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Xefo^{\circledR},$ were -1.56%, 2.16% and -17.12% for $AUC_t,\;C_{max}\;and\;T_{max},$ respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log\;0.90{\sim}log\;1.05$ and $log\; 0.88{\sim}log\;1.17$ for $AUC_t\;and\;C_{max},$ respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Lornocam tablet was bioequivalent to $Xefo^{\circledR}$ tablet.
Objectives : With an assumption of traditional oriental medical theory, to evaluate the effect of tonification/sedation manipulative acupuncture on blood pressure in male normotensives. Methods : This study was a randomized cross-over trial. We enrolled healthy male normotensive subjects, and assigned them randomly to group A or group B. Group A received acupuncture therapy on Shen-Men (He-7) and Nei-Kuan (EH-6) with tonification-manipulation, while group B received it with sedation-manipulation. Blood pressure was assessed every ten minutes for 2 hours. After 3 days of washout period, the subjects were crossed over to the other manipulation, and the same procedures were performed. Results : We observed that blood pressure stimulated by the sedation-manipulation had a tendency to decrease compared to that by the tonification-manipulation. Conclusions : We suggest the sedation manipulation has more synergic effect with the inhibitory effects of Shen-Men and Nei-Kuan on the sympathetic nervous system than the tonification-manipulation.
Objectives : With an assumption of the traditional oriental medical theory, we were to evaluate the effect of tonification/sedation-manipulated acupuncture on autonomic nervous activity in healthy subjects. Methods : This study is a randomized cross-over trial. We enrolled healthy subjects, and assigned them randomly into group A or group B. Group A received acupuncture therapy on Shen-Men (He-7) and Nei-Kuan (EH-6) with tonification-manipulation, while Group B received it with sedation-manipulation. Their heart rate variability was monitored for 2 hours. After 3 days of washout period, the subjects were crossed over to the other manipulation method, and the same procedures were performed. Results : There was no statistical significance in the change of RR, SDNN, LF, HF, and LF/HF ratio between the tonification-manipulated and the sedation-manipulated groups. However, HF curve in the tonification manipulated group showed increasing tendency for 15 minutes after acupuncture. Conclusions :We suggest that the traditional tonification-manipulated acupuncture on Shen-Men and Nei-Kuan could increase parasympathetic activity shortly after acupuncture, but further evaluation on a larger sample size is needed to confirm this suggestion.
Journal of International Academy of Physical Therapy Research
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v.11
no.2
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pp.2021-2027
/
2020
Background: Previous robot-mediated gait training has been proven several limitations such as pointless repeated motion training, decreased presence, etc. In this research, adult stroke patients were participated in robot-mediated gait training accompanied with or without virtual reality program. Objectives: Exploring whether the results indicated virtual reality system has contribution to muscle strength and balance ability. Design: A case series research, cross-over trial. Methods: Eleven participants (male 4, female 7) with adults diagnosed as stroke from medical doctor ware engaged. The participants received 2 treatment sessions of identical duration, robot-assisted gait training with virtual reality and robot-assisted gait training with screen-off randomly crossed over include 1-day for each person of wash-out period. The parameter was muscle activity, the researchers assessed sEMG (surface electromyography). Results: The result showed less muscle activities during training in robot-assisted gait training with virtual reality circumstances, and these indicated muscles were gluteus medius muscle, vastus medialis muscle, vastus intermedius and vastus lateralis muscle, semimembranosus muscle, gastrocnemius-lateral head, and soleus muscle (P<.05). Conclusion: In this study, we analyzed the outcome of muscle activity for clinical inference of robot-assisted gait training with virtual reality (VR). Less muscle activity was measured in the treatment accompanied by VR, therefore, a more systematic, in-depth and well-founded level of follow-up research is needed.
Objective: This study aimed to investigate the abdominal muscle activity difference while performing the abdominal bracing technique focusing on inspiration (abdominal bracing group), the general abdominal bracing technique (general bracing group), and the abdominal hollowing technique (abdominal hallowing group) Design: A cross-sectional study design. Methods: Thirty-three healthy participants were recruited for this study. The participants were allocated to 3 different groups; Abdominal bracing group, general bracing group, and abdominal hallowing group. The surface electromyography was placed over the rectus abdominis, external oblique, and internal oblique muscles to collect the activation of abdominal muscles during the trial. Results: The muscle activity of the abdominal bracing group and general bracing groups was significantly higher in all abdominal muscles than in the abdominal hollowing group (p<0.05) Both rectus abdominis and external oblique muscles showed higher muscle activations in the abdominal bracing group over the general bracing group (p<0.05). However, the ratio of bilateral external obliques and rectus abdominis to bilateral internal obliques was highest when the hollowing technique was applied (p<0.05). Conclusions: The results of study showed the abdominal bracing technique that emphasized inhalation rather than the abdominal hollowing technique or general abdominal bracing technique increased the activity of the abdominal muscles. Therefore, this study is considered to be a data for effective training if the abdominal bracing technique that emphasizes inhalation is applied as a method to increase the activation of the abdominal muscles.
Jin-Kyung Cha;Hyunjin Park;Youngho Kwon;So-Myeong Lee;Dongjin Shin;Jong-Hee Lee
Proceedings of the Korean Society of Crop Science Conference
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2022.10a
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pp.20-20
/
2022
A traditional wheat breeding program needs more than 12-13 years to develop a new cultivar. In recent years, 'Speed breeding (SB)' system, which uses extremely extended photoperiod (22 h), enabled up to 4-6 generations of spring wheat per year. However, since almost 70% of wheat cultivars are winter type, and over 95% of total cultivation area is for winter wheat in Korea, optimized vernalization treatment was essential for improving the SB system. Several vernalization temperatures and durations were tested with various genotypes, and the 4 weeks of 8-10 ℃ vernalization treatment was the most effective to develop 4 generations per year, for both spring and winter type wheat cultivars. This 'Speed vernalization (SV)' system followed by SB, allowed developing a new F6 recombinant inbred lines (RILs) within 2 years. Among the 184 RILs, which derived from a cross between Jokoyung and Joongmo2008, two outstanding lines were selected for yield trial test, and then named Milyang52 and Milyang53. Compared to the traditional wheat breeding program, over 60% of the time was saved to develop these two lines. Marker-assisted selection and backcross were also combined with the SV system. YW3215-2B-1 (Jokoyung*3/Gamet), which has similar agronomic traits with Jokyoung and the same Glu-B1 allele with Garnet, was developed within 2.5 years. Thus, the SV system combined with molecular breeding technology would help breeders to make a new cultivar with less time and high efficiency.
Kim, Choun-sub;Kim, Maengkyu;Kim, Min-ju;Jung, Hyeyoung
Nutrition Research and Practice
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v.14
no.6
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pp.606-620
/
2020
BACKGROUND/OBJECTIVES: Although some juices affect subjective sleep quality, there is a lack of information on the effect of a specific juice on objective sleep quality and heart rate variability (HRV) during sleep; thus the present study investigated whether a blended juice made from natural extracts influenced sleep quality and HRV during sleep in adults with disturbed sleep. SUBJECTS/METHODS: A randomized, crossover study was conducted on twenty-five adults (15/10, female/male) complaining of difficulty initiating or maintaining nighttime sleep (Pittsburgh sleep quality index [PSQI] ≥ 5). During feeding sessions (FS), subjects received sleep-inducing juice made of natural ingredients (250 mL/trial) twice a day for 8 weeks or non-FS (N-FS) for 8 weeks while maintaining normal activities. Sleep quality and parameters were recorded via wearable actigraph for 7 consecutive days, and PSQI scores were assessed before and after the intervention. HRV was also monitored at rest and during sleep. RESULTS: After receiving the sleep-inducing juice intervention (FS), PSQI scores were significantly decreased (P < 0.001) and correlated with a significant decline in fatigue severity scale and visual analogue scale levels (P < 0.05; both). HRV indices of vagal activity were significantly improved during FS (P < 0.05), and no significant differences in N-FS were observed. Sleep efficiency and total sleep time increased significantly (P < 0.05) and sleep latency, total counts, sleep fragmentation index, and movement index, decreased significantly (P < 0.05, all 4) during FS, with no significant differences-observed during N-FS. CONCLUSIONS: This study results demonstrated that an 8-week course of sleep-inducing juice has led to improve sleep quality, suggesting an enhanced cardiac vagal tone during sleep. Thus, it could be a well-tolerated option for adults with disturbed sleep.
A study was made of the efficiency of ammonia N retention by Jowar kadbi (sorghum straw), initially 6.41% crude protein (CP), treated with 4% urea solution. After 30 days the CP in straw that was unchaffed and had been left uncovered was 10.02, and in chaffed straw that had been covered with a polythene sheet was 10.9%. The two treated straws were each fed to six crossbred (HF$\times$Deoni) calves, initially $12{\pm}2$ months old and $86.7{\pm}3.2kg$ bodyweight. They were also given two isocaloric (70% TDN) and isonitrogenous (20% CP) concentrate mixtures differing in calculated Rumen Degradable to Undegradable Dietary Protein ratio (RDP:UDP). Those fed the unchaffed uncovered treated straw (treatment C) received 65 RDP:35UDP and the other group (T1) received concentrate with a 55:45 ratio. The T1 group had the higher DM intake (p<0.01) in total (306 vs 268 kg), per day (4.1 vs 3.6 kg) and per unit bodyweight. Digestibility of DM, OM, CP and NDF, but not ADF, was higher in T1 and that group had the higher daily gain (517 vs 333 g) and higher total gain (38.8 vs 25.0 kg) over the 75 d of the feeding trial. It is concluded that chaffing and covering of Jowar kadbi treated with urea, not likely to be adopted by farmers because of financial constraints, does not confer important benefits. A concentrate supplement (estimated 45% of the CP as UDP) to calves given the treated straw has a beneficial effect on their growth and development.
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