An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Comparative Bioequivalence Study Of Dydrogesterone 40 Mg Tablets Of Mankind Pharma Limited India With Duphaston (Dydrogesterone) 10 Mg (4×10 Mg) Tablets of Abbott India Limited No 45 Mangalam Village Villianur Commune Puducherry India 605110 in Healthy Adult Female Subjects Under Fasting Conditions - NI

Mankind Pharma Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1 Normal healthy adult female subjects of age between 18 to 45 years
•2 Healthy as documented by the medical history physical examination and vital sign assessments
•3 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in
•4 Non smoker
•5 Generally healthy as documented by gynaecological and breast examination
•6 Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study and a negative urine pregnancy test prior to check-in of each period

•1 Evidence of allergy or known hypersensitivity to Dydrogesterone or its inactive ingredients
•2 Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
•3 Any major illness in the last three months or any significant ongoing chronic medical illness
•4 Renal or liver impairment
•5 History of Alcohol addiction or abuse
•6 Consumption of caffeine and or Xanthine containing products cigarettes and tobacco containing products for at least 48 hours before check in and throughout the entire study
•7 Subjects who have taken any prescription medications within 14 days prior to check in and throughout the study and over the counter medicinal products
•8 Subjects who have taken an unusual diet for whatever reason for 48 hours prior to dosing
•9 Subject who had participated in any other study within the 90 days of check-in
•10 History of difficulty in swallowing
•11 History of difficulty in accessibility of veins
•12 Positive results for urine screen of drugs of abuse in urine prior to check-in of this study period
•13 Positive results for alcohol test prior to check-in of each period

发起方

Mankind Pharma Ltd