Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
Condition: Healthy
Intervention: Glucophage XR (Test drug); Glucophage XR (Comparator drug)
Intervention description: Participants received single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions.; Participants received single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions.
Intervention MeSH terms: Metformin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess bioequivalence between metformin hydrochloride
      (Glucophage® XR) manufactured in PT Merck Tbk, Indonesia (test drug) and metformin
      hydrochloride (Glucophage® XR) manufactured in Merck Santé, France (comparator drug)
      following single oral dose administration under fasting condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants has provided written informed consent prior to the conduct of any
             study-related activities

          -  Body mass index of 18 to 25 kilogram per square meter (kg/m^2)

          -  Good physical and mental health status, determined on the basis of medical history and
             physical examination

          -  Vital signs (blood pressure, pulse rate, respiratory rate and body temperature) in
             sitting position within the normal range or showing no clinically relevant deviation
             per the Investigator's opinion

          -  All values for laboratory assessments (hematology, clinical chemistry and urinalysis)
             within the normal range or showing no clinically relevant deviation per the
             Investigator's opinion

          -  No clinically significant abnormality on 12-lead electrocardiogram (ECG) recording as
             judged by the Investigator; corrected QT interval (QTc) (Bazett) should be less than
             equals to (<=) 450 milliseconds (ms)

          -  Non-smoker or smoker less than 10 cigarettes per day

          -  Women of childbearing potential (WOCBP) who are not nursing, are not pregnant, and are
             using highly effective methods of birth control. Female participants may also be
             enrolled if they are postmenopausal or surgically sterilized/ hysterectomized at least
             6 months prior to study participation

          -  WOCBP must have a negative urine pregnancy test at Screening and on each admission
             (Day 1 of each dosing period)

          -  Negative screen for alcohol and drugs abuse (opiate class, barbiturates, cocaine and
             metabolites, amphetamines, cannabinoids and benzodiazepines) at Screening and on each
             Study Check-In (Day -1 of each dosing period)

          -  Negative screen for Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV)
             antibodies and/or Human Immunodeficiency Virus (HIV) antibodies.

        Exclusion Criteria:

          -  Participation in a clinical trial/study within 90 days prior to Screening

          -  Blood donation (equal or more than 300 milliliter [mL]) or significant blood loss
             within 90 days prior to first drug administration

          -  Any surgical or medical condition, including findings in the medical history or in the
             prestudy assessments, or any other significant disease, that in the opinion of the
             investigator, 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 malignant diseases, except in-situ basal cell skin tumors treated with
             curative intent

          -  History of surgery of the gastrointestinal tract which could influence the
             gastrointestinal absorption and/or motility per the Investigator's opinion

          -  History or presence of relevant liver diseases or hepatic dysfunction (laboratory
             result for liver function test greater than equals to (>=) 1.5 upper limit of normal
             (ULN)

          -  History or presence of renal failure or renal dysfunction based on clinical symptoms
             and finding (serum creatinine concentration >1.4 milligram per milliliter (mg/mL)

          -  Ascertained or presumptive hypersensitivity to the active drug substance and/or
             formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in
             general, which the Investigator considers may affect the outcome of the study

          -  Receipt of any prescription or non-prescription medication within 14 days before the
             first drug administration, except for hormonal contraceptives in female, and including
             multivitamins and herbal products (e.g. St John's Wort)

          -  Consumption of large quantities of methylxanthine-containing beverages (> 5 cups of
             coffee/day or equivalent)

          -  Consumption of grapefruit, orange, cranberry or juices of these three fruits, 24 hours
             prior to drug administration

          -  Known lack of participant compliance or inability to communicate or cooperate with the
             Investigator (e.g., language problem, poor mental status)