Bioequivalence study of Dydrogesterone tablets
- Registration Number
- CTRI/2024/01/061471
- Lead Sponsor
- Mankind Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the oral bioequivalence on Dydrogesterone 40 mg tabletsTimepoint: 22 time points <br/ ><br>00.00 00.333 00.50 00.75 01.00 01.25 01.50 01.75 02.00 02.50 03.00 03.50 04.00 05.00 06.000 08.00 10.00 12.00 16.00 20.00 24.00 36.00
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of Dydrogesterone 40 mg tablets in healthy adult female subjectsTimepoint: 22 time points <br/ ><br>00.00 00.333 00.50 00.75 01.00 01.25 01.50 01.75 02.00 02.50 03.00 03.50 04.00 05.00 06.000 08.00 10.00 12.00 16.00 20.00 24.00 36.00