Healthy
Conditions
Keywords
Bioequivalence, Glucophage® XR RM
Brief summary
The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM) manufactured in Merck Jiangsu China (test product) and that manufactured in Merck Darmstadt Germany (reference product) administered under fasted and fed conditions.
Interventions
DRUGTest Glucophage® XR
Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.
DRUGReference Glucophage® XR
Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants who are overtly healthy as determined by medical evaluation, including medical history, ECG recording and physical examination judged by investigator. * Participants with a body weight within 50 to 90 kg (kilogram) and BMI (body mass index) within the range 19 to 26 kg/m2 (kilogram per meter square). * Participants with 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. * Other protocol defined inclusion criteria could apply.
Exclusion criteria
* Participants with 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 in the study or that could interfere with the study objectives, conduct or evaluation. * Participants with history or presence of relevant liver diseases or hepatic or renal dysfunction. * Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion. * Participation in a clinical study within 90 days prior to first drug administration. * Non-acceptance of study high-fat breakfast. * Other protocol defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Metformin | Pre-dose up to 48 hours post-dose on Day 1 and Day 8 |
| Maximum Observed Plasma Concentration (Cmax) of Metformin | Pre-dose up to 48 hours post-dose on Day 1 and Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Plasma Concentrations of Metformin | Pre-dose up to 48 hours post-dose on Day 1 and Day 8 |
| Number of Participants with Treatment-Emergent Adverse Events (AEs) | Baseline up to Day 10 |
| Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination | Baseline up to Day 10 |
Countries
Germany
Outcome results
None listed