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Fasting Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers

NCT05123781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-11-17

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine)

One tablet of the test product was administered orally with 240 ml of water

DRUG

Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK)

One tablet of the Reference product was administered orally with 240 ml of water

Sponsors & Collaborators

  • Joint Stock Company "Farmak"

    lead INDUSTRY

Principal Investigators

  • Vlad Udovytskyi · Joint Stock Company "Farmak"

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2019-04-17
Completion
2019-04-17

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05123781 on ClinicalTrials.gov