glucophage immediate release (gir) china bioequivalence study

Conditions: Healthy

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

Keywords: diabetes mellitus glucophage immediate release (gir) bioequivalence study