Glucophage Immediate Release (GIR) China Bioequivalence Study

• Status: Completed
• Trial end date: 2018-01-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck KGaA, Darmstadt, Germany
• Treatments: Metformin

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