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Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers

NCT05124717 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-11-18

No results posted yet for this study

Summary

The objective of the study is to compare the bioavailability of the Test and Reference products both containing Metformin 500 mg prolonged release tablets (MFM) in healthy male and female volunteers under fed conditions and to assess the bioequivalence of these products based on confidence acceptance intervals of 80.00% to 125.00% for AUC(o-t)and Cmax of MFM as primary endpoints.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Metformin, prolonged-release tablets 500 mg (JSC Farmak, Ukraine)

One tablet of the Test product was administered orally with 240 mL of water.

DRUG

Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)

One tablet of the Reference product was administered orallyn 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
2019-06-25
Primary Completion
2019-07-03
Completion
2019-07-03

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 NCT05124717 on ClinicalTrials.gov