• Journal of Pharmaceutical Investigation
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• v.30 no.1
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• pp.55-59
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• 2000

Bioequivalence of two cisapride tablets, test drug ($Cisple^{\circledR}$ tablet: Hanmi Pharm Co., Ltd.) and reference drug ($Prepulsid^{\circledR}$ tablet: Janssen Pharm. Co., Ltd.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty two healthy male volunteers were divided randomly into two groups and administered the drug orally at the dose of 10 mg as cisapride in a $2{\times}2$ crossover study. There was a week washout period between administrations. Blood samples were taken at predetermined time intervals for 36 hr and the plasma concentration of cisapride was determined by a HPLC method. $AUC_{0-36hr}$ (area under the plasma concentration-time curve from time zero to 36 hr), $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were estimated from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed no difference in $AUC_{0-36hr},\;C_{max}\;and\;T_{max}$ between two products. The apparent differences of these parameters between two products were less than 20% (i.e., 5.38, 6.17 and 0.00% for $AUC_{0-36hr},\;C_{max}\;and\;T_{max},$ respectively). The powers $(1-\beta)$ for $AUC_{0-36hr},\;C_{max}\;and\;T_{max}$ were over 0.9. Minimal detectable differences $(\Delta)$ at ${\alpha}=0.05,\;1-{\beta}=0.8$ were less than 20% (i.e. 17.67, 14.84 and 19.72% for $AUC_{0-36hr},\;C_{max}\;and\;T_{max},$ respectively). The 90% confidence intervals $(\delta)$ for these parameters were also within ${\pm}20%$ $(i.e.\;-4.97\;{\le}{\delta}{\le}\;15.73,\;-2.53{\le}{\delta}{\le}\;14.86\;and\;-11.55{\le}{\delta}{\le}\;11.55$ for $AUC_{0-36hr},\;C_{max}\;and\;T_{max},$ respectively). These results satisfied the criteria of KFDA guidelines for bioequivalence, indicating the two tablets of cisapride were bioequivalent.

• Korean Journal of Clinical Pharmacy
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• v.10 no.1
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• pp.25-29
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• 2000

Bioequivalence of cisapride-containing $Cisaplus^{(R)}$ tablets (Daewoong Co.) to reference $Prepulsid^{(R)}$ tablets (Janssen Co.) was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy volunteers were divided randomly into two groups and administered orally at a cisapride dose of 10 mg in a $2\times2$ crossover design. There was a 1-week washout period between the treatments. Blood samples were taken at predetermined time intervals for 48 hr and the plasma cisapride concentrations were determined by an HPLC with UV detector. The area under the plasma drug concentration-time curve (AUC) was caltulated from time zero to the last sampling time by a linear trapezoidal method. The maximum observed plasma drug concentration ($C_{max}$) and the time to $C_{max}\;(T_{max})$ were estimated directly from the drug concentration-time data. Analysis of variance (ANOVA) showed that the apparent differences for AUC, $C_{max}\;and\;T_{max}$ were $-7.52\%,\;-8.91\%\;and\;-15.55\%$, respectively. The minimum detectable differences for AUC, $C_{max}\;and\;T_{max}$ between formulations were $14.52\%,\;11.57\%\;and\;28.00\%$ respectively, at $\alpha=0.05\;and\;1-\beta=0.8\;levels.\;The\;90\%$ confidence intervals for AUC, $C_{max}\;and\;T_{max}\;were\;-16.00\sim0.97\%,\;-15.67\sim-2.15\%\;and\;-31.88\%\sim0.84\%$, respectively. These results satisfy the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cisapride are bioequivalent.

• Biomolecules & Therapeutics
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• v.7 no.1
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• pp.59-65
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• 1999

A bioequivalence study of the Dong Wha Cisapril tablets(Dong Wha Pharm. Ind. Co., Ltd.) to the Prepulsid tablets(Janssen Korea Ltd.), formulations of cisapride, was conducted. Twenty four healthy Korean male subjects received each formulation at the dose of 5 mg as cisapride in a 2$\times$2 crossover study. There was a 1-week washout period between the doses. Plasma concentrations of cisapride were monitored by an LC/MS method for over a period of 36 h after each administration. AUC(area under the plasma concentration- time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 6.8, -6.6 and 1.8% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences(%) at $\alpha$=0.05 and 1-$\beta$=0.8 were all less than 20% in these parameters between the formulations (i.e., 16.5, 11.4 and 16.4% for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within 20% (i.e., -2.9~ 16.4, -13.2~0.1 and -7.8~ 11.4% for AUC, $C_{max}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the two formulations of cisapride are bioequivalent and, thus, may be prescribed interchangeably.hangeably.y.hangeably.

• Proceedings of the KOR-BRONCHOESO Conference
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• 1996.04a
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• pp.83-83
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• 1996

저자들은 이 연구를 통해 인두신경증의 원인적 요소를 알아보고 진단에 필요한 검사법의 선정 및 치료율을 향상시킬 수 있는 약제의 선택에 도움을 받고자 하였다. 상세한 문진과 이학적 검사를 통해 선정된 73명을 대상으로 전례에서 식도조영술, 식도위 내시경, 식도내압 검사 및 24시간 산도(pH)검사를 시행하였다. 최소 추적기간은 3개월 이었으며 아래와 같은 결과를 얻었다. 1. 대상례중 남자는 24명, 여자는 49명이었다. 2. 식도조영술상 54례(74%)에서 정상소견을 보였다. 3. 식도내압검사상 49례(67.1%)에서 정상소견을 보였다. 4. 24시간 산도검사상 15례에서 명확한 위식도 역류가 관찰되었으며 17례에서는 경도의 위식도 역류를 보여 총 43.8%에서 위식도 역류가 확인되었다. 5. Omeprazole, prepulsid 및 diazepam의 복합요법으로 총 61례(83.6%)에서 증상이 완전소실되거나 호전되었다. 특히 24시간 산도검사에서 위식도역류가 있었던 예에서는 87.5%에서 호전이상의 반응이 있었으며 위식도역류가 없었던 예에서는 80.5%에서 반응을 보였다. 이상의 결과로 보았을 때 식도조영술은 진단적인 가치가 떨어지며 식도내압 검사와 함께 24시간 산도측정이 치료제의 선택과 치료율의 향상에 기여할 수 있다고 사료되었다.

• Tuberculosis and Respiratory Diseases
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• v.44 no.4
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• pp.836-843
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• 1997

Background : The prevalence of Gastro-esophageal reflux(GER) in patients with asthma is estimated to be 50~60% and treatment of GER has been shown to improve asthma symptoms in Western. But GER has been known to be less common in Eastern and GER prevalence rates in asthmatics are not available in Korea. Method : We compared the prevalence rate of GER in 42 patients with asthma to that in 20 healthy normal controls and examed the efficacy of new prokinetic drug, cisapride(40mg/day, 8weeks) in patients with GER and asthma. For acid GER to be considered pathological, 24 hour esophageal pH monitoring should reveal values exceeding upper limit of 95 percentile for at least one of 6 parameter of DeMesseter's table. Result : The results showed GER was more common in patients with asthma(11/42, 26.2%) than normal controls(3/20, 15%) and asthmatics group showed a significant longer supine time pH<4(%) and total time pH<4(%), and more reflux episodes as compared with normal control group. After 4 asthmatics with GER were treated with cisapride, their asthma symtom scores, FEV1 and composite scores of pH monitoring were improved. Conclusion : GER is more common in asthmatics than in normal controls in Korea and prepulsid reduces asthma symptoms in patients with GER and asthma.