NCT03467945

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

Randomized, Open Label, Single Dose, 4 Treatment, 4 Period, Crossover Design (4 x 4) Trial to Evaluate the Bioequivalence and Secondarily Drug - Drug Interaction of Fixed Combination of Metformin Tablets 1000 mg/Gliclazide 30 mg MR, Compared With the Co-administration of Individual Tablets and Individual Administration of Each Single Tablet (Metformin 1000 mg XR and Gliclazide 30 mg MR) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-02-16
• Primary completion: 2018-04-29
• Completion: 2018-04-29
• First posted: 2018-03-16
• Last updated: 2019-07-16
• Results posted: 2019-07-16

Locations

1 site across 1 country: Germany