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Glucophage XR

Aliases
Glucophage® XR Reference, Glucophage® XR RM Test, Glucophage® XR Tablets 500 mg, Metformin hydrochloride
Name
Metformin Hydrochloride
INN Name
METFORMIN HYDROCHLORIDE
FDA Approved
Yes

7 clinical trials

1 organization

1 indication

1 document

Indication
Healthy
Clinical trial
A Randomized Phase I, Open-Label, Active-Controlled Study Assessing The BE Between Single Doses of 500 mg GXR RM Tablets and 500 mg GXR Tablets Under Fasted and Fed State in Two 2-Way Crossover Groups of Healthy Participants
Status: Completed, Estimated PCD: 2022-03-11
Clinical trial
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
Status: Completed, Estimated PCD: 2023-01-03
Clinical trial
Single-Dose Fasting In Vivo Bioequivalence Study of Metformin Hydrochloride ER Tablets (500 mg; Mylan) and Glucophage® XR Tablets (500 mg; Bristol-Myers Squibb) in Healthy Volunteers
Status: Completed, Estimated PCD: 2002-10-01
Clinical trial
Single-Dose Food In Vivo Bioequivalence Study Metformin Hydrochloride ER Tablets (500 mg; Mylan) and Glucophage® XR (500 mg; Bristol-Myers Squibb) in Healthy Volunteers
Status: Completed, Estimated PCD: 2002-11-01
Clinical trial
Single-Dose Food In Vivo Bioequivalence Study Metformin Hydrochloride ER Tablets (750 mg; Mylan) and Glucophage XR (750 mg; Bristol-Myers Squibb) in Healthy Volunteers
Status: Completed, Estimated PCD: 2003-12-01
Clinical trial
Single-Dose Fasting In Vivo Bioequivalence Study of Metformin Hydrochloride ER Tablets (750 mg; Mylan) and Glucophage® XR Tablets (750 mg; Bristol-Myers Squibb) in Healthy Volunteers
Status: Completed, Estimated PCD: 2003-12-01
Clinical trial
Single-Dose Fasting In Vivo Bioequivalence Study of Metformin Hydrochloride ER Tablets (500 mg; Mylan) and Glucophage® XR Tablets (500 mg; Bristol-Myers Squibb) in Healthy Volunteers
Status: Completed, Estimated PCD: 2004-03-01
Document
DailyMed Label: Metformin Hydrochloride
Organization
State of Florida DOH Central Pharmacy