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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
84
Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.
Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.
Research Site
Darmstadt, Germany
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
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Maximum Observed Plasma Concentration (Cmax) of Metformin
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Pharmacokinetic Plasma Concentrations of Metformin
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Number of Participants with Treatment-Emergent Adverse Events (AEs)
Time frame: Baseline up to Day 10
Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination
Time frame: Baseline up to Day 10
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