Research Site
Darmstadt, Germany
NCT Number: NCT05463094
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Darmstadt, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.
Other names: Metformin hydrochloride
Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.
Other names: Metformin hydrochloride
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Time frame: Baseline up to Day 10
Time frame: Baseline up to Day 10
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Industry
A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage® XR RM Tablets (Merck/China Jiangsu-Manufactured) and 500 mg Glucophage® XR RM Tablets (Merck/Germany Darmstadt-Manufactured) Under Fed and Fasted State in Healthy Participants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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