A Study to Assess the Food Effect on Bioavailability of Metformin/Gliclazide in Healthy Participants

• Status: Completed
• Trial end date: 2018-04-22
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the food effect on bioavailability of Metformin/Gliclazide fixed dose combination tablet in fed and fasted state.

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

Details

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

Criteria

Inclusion Criteria:

• Ethnicity: Mexicans

• Weight between 55 and 95 kilogram (kg)

• Body mass index between 18 and 27 kilogram per meter square (kg/m^2)

• Nonsmokers or participants who do not smoke more than 5 cigarettes or 1 pipe a day

• Good physical and mental health based on the clinical history and physical examination

• All results from blood chemistry, hematology, and urinalysis should be within normal ranges or without clinically significant deviations as per Principal Investigator's judgment

• Hematology complete blood count [CBC]: hematocrit and hemoglobin must be above the lower limit; upper limit may range up to 15 percent (%)

• Liver Function Test range as defined in the protocol

• Electrocardiogram (12 leads) without clinically significant pathological signs

• 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)

• Vital signs (blood pressure and pulse) in supine position within normal ranges or with clinically significant abnormalities as per the Principal Investigator's judgment

• All women of childbearing potential who are not pregnant or breastfeeding and who are using a highly effective contraceptive method for at least one month before and following dosing

• Negative result for alcohol breath test and urine test for drugs of abuse at screening and at each day -1 of the 2 treatment periods

• Negative serology tests for human immunodeficiency virus (HIV1 and HIV2 antibodies), hepatitis A (HAV), hepatitis B (HBV), hepatitis C (HCV) and venereal disease research laboratory (VDRL) test screening

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Participants who have received any investigational drug within 21 days prior to the study start

• Participants who have donated or lost 450 milliliter (mL) or more of blood within 21 days prior to the study start

• Participants with history of cardiovascular, renal, liver, metabolic, gastrointestinal, neurological, endocrine, or hematopoietic (any type of anemia) diseases; mental disease, surgery or other organic abnormalities which might affect the study of the investigational drug pharmacokinetics

• History of gastrointestinal tract surgery

• Participants with history of hypersensitivity to the study drug and/or any formulation's ingredient; history of drug induced anaphylaxis

• Participants who take any other drug 30 days before the study drug dose and for which at least seven elimination half-lives had not elapsed

• Renal failure or renal impairment assessed by using the Cockcroft-Gault formula

• Participant's disagreement or lack of capacity to communicate and cooperate with the Investigator, lack of legal capacity or limited legal capacity which prevent him/her from continuing in the study

• Refusal of the high-fat diet which is necessary to assess the food effect. Considerable deviations to the diet's normal nutritional patterns

• Participants who have smoked tobacco, having drunk alcohol, or xanthines containing beverages or food above 600 mg of caffeine a day those who have had grilled food within 24 h prior to the drug dosing

• Intake of grapefruit, orange, cranberries or their juices within 14 days prior to the drug's dosing and throughout the study

• Legal inability or limited legal capacity

• Incarcerated participants

• Participants who have been exposed to agents known as liver enzyme systems' inducers or inhibitors, or who have taken potentially toxic drugs within 30 days prior to the study

• Other protocol defined exclusion criteria could apply