Glucophage Immediate Release (GIR) China Bioequivalence Study
Condition: Healthy
Intervention: Test GIR; Reference GIR
Intervention description: Participants received 500 milligrams (mg) test GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).; Participants received 500 mg reference GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
Intervention MeSH terms: Metformin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetes Mellitus; Glucophage Immediate Release (GIR); Bioequivalence Study

Summary:

      The study will assess the bioequivalence between single doses of glucophage immediate release
      (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants had given written informed consent before any trial-related activities

          -  Chinese male and female participants (at least 1/4 of each gender per trial group)

          -  Aged between 18 and 55 years, inclusive

          -  Weighed: 50 to 80 kilogram (kg); Body mass index (BMI): 18 to 30 kg per meter square

          -  Nonsmoker since at least 3 months

          -  Good physical and mental health status, determined on the basis of the medical history
             and a physical examination

          -  All values for biochemistry and hematology tests of blood and urine within the normal
             range or showied no clinically relevant deviation as judged by the Investigator

          -  Electrocardiogram recording (12-lead ECG) without signs of clinically relevant
             pathology was judged by the Investigator

          -  Vital signs (blood pressure, pulse, body temperature, and respiration) in sitting
             position within the normal range or showing no clinically relevant deviation was
             judged by the Investigator

          -  All women of childbearing potential (WOCBP) who were not nursing, were not pregnant,
             and were using highly effective methods of birth control

          -  Negative screen for alcohol and drugs of abuse (cannabis, benzodiazepines,
             barbiturates, opiates, cocaine, and methyl amphetamine) were screened at and on
             admission

          -  Negative screen for hepatitis A virus (HAV) antibodies, hepatitis B surface antigen
             (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV)
             antibodies, and Treponema pallidum (TP) antibodies

        Exclusion Criteria:

          -  Participation in a clinical trial within 90 days prior to first drug administration

          -  Blood donation (equal or more than 500 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
             pretrial 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 trial or that could interfere with the trial objectives, conducted
             or evaluated

          -  History of surgery of the gastrointestinal tract which could influence the
             gastrointestinal absorption and/or motility according to the Investigator's opinion

          -  History or presence of relevant liver diseases or hepatic dysfunction Allergy:
             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 considered affectted the outcome of the trial

          -  Receipt of any prescription or nonprescription medication within 2 weeks before the
             first IMP administration, including multivitamins and herbal products (example, St
             John's Wort, or traditional Chinese medicines), except paracetamol

          -  Renal failure or renal dysfunction (creatinine clearance < 80 mL/minute) as assessed
             by using the estimated measure with the Modification of Diet in Renal Disease (MDRD)
             equation

          -  Known lack of participant compliance or inability to communicate or cooperate with the
             Investigator (example, language problem and poor mental status)

          -  Nonacceptance of trial high-fat breakfast (example, vegetarians, vegans, and
             participants followed special diets)

          -  Consumption of large quantities of methyl xanthine-containing beverages (> 5 cups of
             coffee/day or equivalent)

          -  Consumption of grapefruit, cranberry or juices of these fruits, from 14 days prior to
             drug administration until collection of the last pharmacokinetic sample in Period 2

          -  Any contraindication to Glucophage

          -  Abnormal and clinically significant chest X-ray finding at screening