A Study to Assess the Food Effect on Bioavailability of Metformin/Gliclazide in Healthy Participants
Condition: Healthy
Intervention: Metformin/Gliclazide Fixed Combination
Intervention description: Participants will receive single oral dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting or fed state.
Intervention MeSH terms: Metformin; Gliclazide
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Metformin; Bioavailability; Food effect; Pharmacokinetics

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

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

          -  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