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

NCT ID: NCT03467945

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-16
• Study Completion Date: 2018-04-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Sequence 1

Participants received single oral dose of metformin 1000 milligram (mg) and gliclazide 30 mg fixed combination tablet in treatment period 1 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg in treatment period 3 and then a single oral dose of gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.

Group Type: EXPERIMENTAL

Metformin/Gliclazide Fixed Combination

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

Gliclazide

Intervention Type: DRUG

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

Treatment Sequence 2

Participants received concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 1 followed by single oral dose of gliclazide 30 mg in treatment period 2 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 3 and then single oral dose of metformin 1000 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.

Group Type: EXPERIMENTAL

Metformin/Gliclazide Fixed Combination

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

Gliclazide

Intervention Type: DRUG

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

Treatment Sequence 3

Participants received single oral dose of metformin 1000 mg in treatment period 1 followed by single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 2 followed by single oral dose of gliclazide 30 mg in treatment period 3 and then concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 4. Each treatment period was separated by a 14-day wash-out period.

Group Type: EXPERIMENTAL

Metformin/Gliclazide Fixed Combination

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

Gliclazide

Intervention Type: DRUG

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

Treatment Sequence 4

Participants received single oral dose of gliclazide 30 mg in treatment period 1 followed by single oral dose of metformin 1000 mg in treatment period 2 followed by concomitant oral dosing of metformin 1000 mg and gliclazide 30 mg in treatment period 3 and then single oral dose of metformin 1000 mg and gliclazide 30 mg fixed combination tablet in treatment period 4. Each treatment period was separated by a 14-day wash-out period.

Group Type: EXPERIMENTAL

Metformin/Gliclazide Fixed Combination

Intervention Type: DRUG

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

Metformin

Intervention Type: DRUG

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

Gliclazide

Intervention Type: DRUG

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

Interventions

Metformin/Gliclazide Fixed Combination

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

Intervention Type: DRUG

Metformin

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

Intervention Type: DRUG

Gliclazide

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants has given written informed consent before any study-related activities were carried out
• Ethnic origin: Mexicans
• Weight between 55 and 95 kilogram (kg)
• Body mass index between 18.5 and 27 kilogram per meter square (kg/m^2)
• Not smoking more than 5 cigarettes or 1 cigar or 1 pipe per day (or non smokers)
• Good physical and mental health status
• Vital signs (blood pressure and pulse) in supine position within the normal range or showing no clinically relevant deviation as judged by the Investigator
• Electrocardiogram recording (12-lead) without signs of clinically relevant pathology in particular QTc (Bazett) <450 milliseconds (ms)
• All values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator
• All women of childbearing potential (WOCBP) were not nursing, were not pregnant, and were using highly effective methods of birth control for a period of at least one month before and after dosing
• All women of childbearing potential must have negative tests for pregnancy at screening, and at day -1 for each treatment period and at end of trial (EOT)
• Negative screen for alcohol and drugs of abuse at Screening and on each admission
• Negative screen for Hepatitis B surface (HBs) antigens, Hepatitis C Virus (HCV) antibodies, Hepatitis A Virus (HAV) antibodies and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies

Exclusion Criteria

• Participation in a clinical trial within 90 days prior to first drug administration
• Participants who have donated more than 500 milliliter (mL) of blood or who have lost significantly (more than 450 mL) blood within 90 days prior to first drug of administration
• Any surgical or medical condition, constitutes a risk or a contraindication for the participation of the participant in the study or that could interfere with the study objectives, conduct or evaluation
• History of surgery of the gastrointestinal tract
• Allergy
• Receipt of any prescription or non-prescription medication within 2 weeks before the first study drug administration
• Renal failure or renal dysfunction (creatinine clearance less than [<] 80 mL/minute) as assessed by using the estimated measure with the Cockcroft-Gault formula
• Known lack of participant compliance or inability to communicate or cooperate with the Investigator
• Considerable diet deviations from normal nutritional patterns
• Consumption of large quantities of methylxanthine-containing beverages (more than 600 milligram [mg] caffeine / day: one cup [240 mL] of coffee contains approx. 100 mg of caffeine, one cup of tea approximately 30 mg and one glass of cola approximately 20 mg caffeine)
• Consumption of grapefruit, orange, cranberry or juices of these fruits, 14 days prior to drug administration and during the study
• Legal incapacity or limited legal capacity
• Participants kept in detention

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

Please Contact the Merck KGaA Communication Center

Darmstadt, , Germany

Countries

Germany

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

EMR200763_003

Identifier Type: -

Identifier Source: org_study_id