None listed
Conditions
Interventions
Intervention1: Metformin + PCOSNIL: Metformin 500 mg and PCOSNIL 500 mg single dose for a single day
Control Intervention1: Metformin: Metformin 500 mg single dose for a single day
Sponsors
Acuere Biosciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants aged 18 - 55 years. 2. Body mass index (BMI) between 18.5 and 30 kg/m2 3. No significant medical history or current medical conditions 4. Not on any medications
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Known case or history of hypersensitivity to metformin 3. Gastrointestinal disorders affecting drug absorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under curve (AUC) from 0 to t (AUC 0 to t) and 0 to infinity ( AUC 0 to infinity) and maximum plasma concentration (C Max)Timepoint: 0hr, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 3.5hrs,4hrs,5hrs, 6hrs, 8hrs, 10hrs, 12hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum concentration (T max), Elimination half life (t1/2) and any adverse effects reportedTimepoint: 0hr, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 3.5hrs,4hrs,5hrs, 6hrs, 8hrs, 10hrs, 12hrs | — |
Countries
India
Contacts
Public ContactDr Nithya Gogtay
Seth. G. S. Medical College and KEM Hospital, Mumbai
Outcome results
None listed