None listed
Conditions
Interventions
Intervention1: Dydrogesterone: 40 mg Tablets
Single Oral Dose
Control Intervention1: Duphaston (Dydrogesterone): 10 mg 4 tablets
Single oral dose
Sponsors
Mankind Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the oral bioequivalence on Dydrogesterone 40 mg tabletsTimepoint: 22 time points 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
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of Dydrogesterone 40 mg tablets in healthy adult female subjectsTimepoint: 22 time points 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 | — |
Countries
India
Contacts
Public ContactDr R Gokul Raj
SpinoS Lifescience and Research Private Limited
Outcome results
None listed