Fasting Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers
Status:
Completed
Trial end date:
2019-04-17
Target enrollment:
Participant gender:
Summary
The primary objective was to compare the rate and extent of absorption of Metformin XR after
administration of a Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak,
Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono
Ltd, UK), administered as a single dose in healthy subjects under fasting conditions.
The adverse events, physical examinations and vital signs were reported for the evaluation of
safety.