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Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers

NCT05124730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-11-18

No results posted yet for this study

Summary

This study was designed to compare the bioavailability of the Test Product Metformin 500mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fasting conditions.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Metformin 500mg prolonged release tablets (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 Reference (R) 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
2021-05-21
Primary Completion
2021-05-29
Completion
2021-05-29

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 NCT05124730 on ClinicalTrials.gov