Bioequivalence and Drug - Drug Interaction Study of Metformin/Gliclazide in Healthy Participants
Condition: Healthy
Intervention: Metformin/Gliclazide Fixed Combination; Metformin; Gliclazide
Intervention description: Participants received single oral dose of Metformin and Gliclazide fixed combination tablet in treatment period 1, 2, 3 or 4.; Participants received single oral dose of Metformin tablet in treatment period 1, 2, 3 or 4.; Participants received single oral dose of Gliclazide tablet in treatment period 1, 2, 3 or 4.
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: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Metformin; Gliclazide; Bioequivalence; Drug-drug Interaction; Pharmacokinetics

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.
    

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

          -  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