An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose oral bioequivalence study of Obeticholic acid 10 mg tablet (T) Manufactured by G.C.Chemie Pharmie Ltd at M/s. Steril-Gene Life Science (P) Ltd., No. 45, Mangalam Main Raod,Mangalam Village, Villianur Commune, Puducherry – 605 110 with OCALIVA (Obeticholic acid) Tablets 10 mg (R) Manufactured by Intercept Pharmaceuticals in normal healthy, adult, male subjects under Fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of Obeticholic acid 10
研究概览
简要总结
An open label, randomized, balanced, two treatment, two sequence, twoperiod, cross-over, single-dose oral bioequivalence study of Obeticholicacid 10 mg tablet (T) Manufactured by G.C.Chemie Pharmie Ltd at M/s.Steril-Gene Life Science (P) Ltd., No. 45, Mangalam Main Raod,Mangalam Village, Villianur Commune, Puducherry – 605 110 withOCALIVA® (Obeticholic acid) Tablets 10 mg (R) Manufactured byIntercept Pharmaceuticals in normal healthy, adult, male subjects underFasting condition
CDSCO recommend to conduct BE study as part of Subsequent New Drug application
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy, adult male subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
- •Having a Body Mass Index (BMI) between 18.50 to 24.99 kg/m2 (both inclusive) at the time of screening.
- •Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
- •Able to comply with the study procedures, in the opinion of the principal investigator.
- •Compliance with study specific restrictions and prohibitions.
- •Able to give voluntary written informed consent for participation in the trial.
- •Non Smoker and Non Alcoholic.
排除标准
- •If any subject is having any of the following conditions, then exclude him/her from participation in this study: Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
- •Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening.
- •Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
- •Pulse rate below60 beats/minute or above 100 beats/minute at the time of screening.
- •Respiratory rate below 15 or above 20 breaths per minute.
- •Oral temperature below 96.2o F or above 99.8 o F at the time of screening.
- •Ingestion of any medicine at any time within 14 days prior to IP administration in period I.
- •In any such case subject selection will be at the discretion of the principal investigator.
- •Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in of each period.
- •An unusual or abnormal diet within 48.00 hours prior to study check-in of each period, whatever reason e.g. because of fasting due to religious reasons.
- •The presence of clinically significant abnormal laboratory values during screening.
- •Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis.
- •A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.
- •Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.
- •Positive HIV, VDRL/RPR, Hepatitis B and C tests.
- •Difficulty in swallowing capsule/tablet.
- •Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
- •Prior to check-in of Period-One, complete the Inclusion and Exclusion Criteria Form for each volunteer.
- •Only suitable volunteers should be allowed to participate in the study.
结局指标
主要结局
To compare the rate and extent of absorption of Obeticholic acid 10
时间窗: A single pre-dose (0.00) blood sample of 3.0 mL will be collected in each period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTAvacutainers. | The post-dose blood samples of 3.0 mL each will be collected at 00.17, 00.33, 00.50, 00.67, 00.83, 01.00, 01.25, 01.50, 01.75, 02.00, 03.50, 05.00, 06.50, 08.00, 09.50, 11.00, 14.00, 18.00, 24.00, 36.00, | 48.00 and 72.00 hours post drug administration in each period. | 36.00, 48.00 and 72.00 hours Ambulatory Visit
mg tablet (T) Manufactured by G.C. Chemie Pharmie Ltd, India with
时间窗: A single pre-dose (0.00) blood sample of 3.0 mL will be collected in each period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTAvacutainers. | The post-dose blood samples of 3.0 mL each will be collected at 00.17, 00.33, 00.50, 00.67, 00.83, 01.00, 01.25, 01.50, 01.75, 02.00, 03.50, 05.00, 06.50, 08.00, 09.50, 11.00, 14.00, 18.00, 24.00, 36.00, | 48.00 and 72.00 hours post drug administration in each period. | 36.00, 48.00 and 72.00 hours Ambulatory Visit
OCALIVA®(Obeticholic acid) Tablets10mg (R) Manufactured by Intercept Pharmaceuticals.
时间窗: A single pre-dose (0.00) blood sample of 3.0 mL will be collected in each period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTAvacutainers. | The post-dose blood samples of 3.0 mL each will be collected at 00.17, 00.33, 00.50, 00.67, 00.83, 01.00, 01.25, 01.50, 01.75, 02.00, 03.50, 05.00, 06.50, 08.00, 09.50, 11.00, 14.00, 18.00, 24.00, 36.00, | 48.00 and 72.00 hours post drug administration in each period. | 36.00, 48.00 and 72.00 hours Ambulatory Visit
次要结局
- To monitor the adverse events and to ensure the safety of the subjects(following administration of a single dose of Obeticholic acid 10 mg tablet.)