Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)

Launched by MERCK KGAA, DARMSTADT, GERMANY · Jun 21, 2018

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Eligibility criteria

• Inclusion Criteria:
• • Overtly healthy as determined by medical evaluation, including medical history and a physical examination
• • Have a body weight within 50 to 90 kilogram (kg) and Body mass index (BMI) within the range 18 to 30 kg per meter square (kg/m\^2) (inclusive)
• • Chinese male and female (at least 1/4 of each gender per study group)
• • A male participant must agree to use and to have their female partners use a highly effective contraception (that is, methods with a failure rate of less than 1 percent per year) for a period of at least 1 month before and after dosing
• • A female is eligible if she is not pregnant (that is, after a confirmed menstrual period and a negative serum pregnancy test), not breastfeeding, and at least one of the following conditions applies
• • Is not a woman of childbearing potential (WOCBP) OR
• • Is a WOCBP who agrees to use a highly effective contraceptive method (that is, has a failure rate of less than 1 percent per year) for a period of at least 1 month before and after dosing
• • Can give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
• • Non-smoker (0 cigarettes, pipes, cigars, or others) since at least 3 months
• • All values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator
• • Electrocardiogram recording (12 lead ECG) without signs of clinically relevant pathology as judged by the Investigator.
• • Pulse, body temperature, and respiration in sitting position within the normal range or showing no clinically relevant deviation as judged by the Investigator. Blood pressure in sitting position within normal range: greater than or equals to (\>=) 90 millimeter of mercury (mmHg) and less than or equal to (=\<) 139 mmHg for systolic blood pressure; \>= 60 mmHg and =\< 90 mmHg for diastolic blood pressure
• • Negative screen for alcohol and drugs of abuse (cannabis, benzodiazepines, barbiturates, opiates, cocaine, and methyl amphetamine) at screening 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 pre-study 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 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 considers may affect the outcome of the study
• • Receipt of any prescription or non-prescription medication within 2 weeks before the first Investigational medicinal product (IMP) administration, including multivitamins and herbal products (that is St John's Wort, or traditional Chinese medicines), except for the permitted medications
• • Renal failure or renal dysfunction (creatinine clearance \[Ccr\] \< 80 mL/minute) as assessed by using the estimated measure with the Cockcroft-Gault equation.
• • Known lack of participant compliance or inability to communicate or cooperate with the Investigator (example, language problem, poor mental status)
• • Non-acceptance of study high-fat breakfast (example, vegetarians, vegans and participants who follow special diets)
• • Consumption of large quantities of methylxanthine-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 Pharmacokinetics sample in Period 2
• • Any contraindication to Glucophage
• • Abnormal and clinically significant chest X-ray finding at screening