Glucophage Immediate Release (GIR) China Bioequivalence Study

Launched by MERCK KGAA, DARMSTADT, GERMANY · Jan 5, 2018

Keywords

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Gender

ALL

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