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

• Status: Completed
• Trial end date: 2018-04-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Gliclazide; Metformin

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

• Other protocol defined inclusion criteria could apply

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

• Other protocol defined exclusion criteria could apply