A Phase 1 interventional study of Metformin and Glucophage® in Bioequivalence, sponsored by Geropharm. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.
Sponsored by Geropharm · Phase 1, Interventional, and Basic science
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck )
Study to evaluate the bioequivalence of orally administered metformin preparations, immediate release tablets, 1 000 mg in normal healthy subjects under fasting and fed conditions
Exclusion Criteria:
First aIntervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition Third Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition
Drug: Metformin
Second Intervention Period: Single administered dose of Glucophage® ( 1 000 mg tablet immediate release) in a fasting condition Fourth Intervention Period: Single administered dose of Glucophage® ( 1 000 mg tablet immediate release) in a fed condition
Drug: Glucophage®
First aIntervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition
Also known as: fasting condition
Second Intervention Period: Single administered dose of Glucophage® (1 000 mg tablet immediate release) in a fasting condition
Also known as: fasting condition
Third Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition
Also known as: fed condition
Fourth Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition
Also known as: fed condition
Cmax
Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)
Time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 hours post-dose
AUC(0-t)
Pharmacokinetics of metformin by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 hours post-dose
Plan to share: No
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Geropharm