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

NCT ID: NCT03467971

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2018-04-22

Brief Summary

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

Conditions

Healthy

Study Design

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

Study Groups

Metformin-Gliclazide (fasted), Then Metformin-Gliclazide (fed)

Participants received single dose of Metformin 1000 milligram (mg) and Gliclazide 30 mg fixed combination tablet in fasting state in treatment period 1 followed by single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fed state in treatment period 2. Each treatment period was separated by a 14-day wash-out period.

Group Type: EXPERIMENTAL

Metformin/Gliclazide Fixed Combination

Intervention Type: DRUG

Participants will receive single oral dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting or fed state.

Metformin-Gliclazide (fed), Then Metformin-Gliclazide (fasted)

Participants received single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fed state in treatment period 1 followed by single dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting state in treatment period 2. Each treatment period will be separated by a 14-day wash-out period.

Group Type: EXPERIMENTAL

Metformin/Gliclazide Fixed Combination

Intervention Type: DRUG

Participants will receive single oral dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting or fed state.

Interventions

Metformin/Gliclazide Fixed Combination

Participants will receive single oral dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting or fed state.

Intervention Type: DRUG

Eligibility 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

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

• 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

CECYPE

Mexico City, , Mexico

Countries

Mexico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EMR200763_004

Identifier Type: -

Identifier Source: org_study_id