An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Crossover Truncated Four Period Fully Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Relugolix 120 mg Tablets Manufactured By BDR Pharmaceuticals Internationals Pvt Ltd India With Orgovyx (Relugolix) 120 MG Tablets Distributed By Sumitomo Pharma America Inc In Healthy Adult Human Male Subjects Under Fasting Conditions - NI

BDR Pharmaceuticals Internationals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•Normal healthy adult human male subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2
•Subjects who have no evidence of underlying disease during screening and
•check-in and whose screening is performed within 21 days of check in
•Subjects whose screening laboratory values are within normal limits or
•considered by the physician or principal/clinical investigator to be of no clinical
•significance
•Healthy as documented by the medical history physical examination (including
•but may not be limited to an evaluation of the cardiovascular gastrointestinal
•respiratory musculoskeletal and central nervous system) and vital sign
•assessments
•Generally healthy as documented by 12 lead electrocardiogram (ECG) Chest X Ray
•and clinical laboratory assessments
•Willing to consume Ovo lacto-vegetarian diet
•Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
•If male and sexually active the subject is willing to commit to 2 acceptable
•methods of birth control for the duration of the study up to 14 days from the last dose

•Evidence of allergy or known hypersensitivity to Relugolix or its inactive ingredients
•Any major illness in the last three months or any significant ongoing chronic medical illness
•Renal or liver impairment
•Consumption of caffeine and or Xanthine containing products cigarettes and tobacco
•containing products for at least 48.00 hours prior to check-in

发起方

BDR Pharmaceuticals Internationals Pvt Ltd