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Bioequivalence and Drug - Drug Interaction Study of Metformin/Gliclazide in Healthy Participants

NCT03467945 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-16

Study results available
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Summary

This study investigated the bioequivalence and drug-drug interaction of Metformin/Gliclazide fixed combination tablet compared to co-administration of individual tablets of Metformin and Gliclazide.

Conditions

  • Healthy

Interventions

DRUG

Metformin/Gliclazide Fixed Combination

Participants received single oral dose of Metformin and Gliclazide fixed combination tablet in treatment period 1, 2, 3 or 4.

DRUG

Metformin

Participants received single oral dose of Metformin tablet in treatment period 1, 2, 3 or 4.

DRUG

Gliclazide

Participants received single oral dose of Gliclazide tablet in treatment period 1, 2, 3 or 4.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

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
2018-02-16
Primary Completion
2018-04-29
Completion
2018-04-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT03467945 on ClinicalTrials.gov