CTRI/2026/01/102198尚未招募不适用
An open label, randomized, balanced, two treatment, two sequence, two period, two-way crossover, single-dose, oral bioequivalence study of Riociguat 2.5 mg tablets (T) manufactured by Zenara Pharma Pvt. Ltd., Plot No: 83/B, 84 & 87-96, Phase III, IDA Cherlapally, Hyderabad-500051, India with ADEMPAS® (riociguat) 2.5 mg tablets (R) manufactured for Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981, United states in normal healthy, adult male subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
After an overnight fasting of at least 10.00 hours, a single dose of Riociguat 2.5 mg tablets (T) manufactured by Zenara Pharma Pvt. Ltd., Plot No: 83/B, 84 & 87-96, Phase III, IDA Cherlapally, Hyderabad-500051, India or ADEMPAS® (riociguat) 2.5 mg tablets (R) manufactured for Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981, United states will be administered along with 240±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received all the ‘treatments’ by the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Volunteers who accepts for participating in this study must be: 1) 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 29.99 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.
排除标准
- •If any subject is having any of the following conditions, then exclude him from participation in this study: 1) Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •Subjects with a history of previous use of medicines like ACE and ARB inhibitor.
- •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 5) Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening.
- •Pulse rate below 60 beats/minute or above 100 beats/minute at the time of screening.
- •Body temperature below 96.2o F or above 99.8o F at the time of screening.
- •SpO2 less than 94% at the time of screening.
- •Use of any prescribed medication (including herbal remedies and vitamins) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies and vitamins) during one week prior to study initiation and throughout the study.
- •In any such case subject selection will be at the discretion of the Principal Investigator.
- •Smokers and Alcoholics.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
- •An unusual or abnormal diet within 48.00 hours prior to study check-in, 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 analyzer test.
- •A history of difficulty with donating blood or having donated blood in the preceding 90 days for males 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 for males preceding the start of the study.
- •Difficulty in swallowing tablets.
- •Positive HIV, VDRL/RPR, Hepatitis B and C tests.
- •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.
研究者
Dr Harisha C
Notrox Research Pvt Ltd
研究点 (1)
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