NCT04317703View on ClinicalTrials.gov

Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 19, 2020

Primary Completion Date

September 5, 2020

Study Completion Date

September 5, 2020

Conditions
Type 2 Diabetes
Interventions
DRUG

Gemigliptin tartrate sesquihydrate and metformin

Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.

DRUG

gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release

"Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin.~Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base)."

Trial Locations (1)

Unknown

International Bio Service Co., Ltd., Nakhon Pathom

Sponsors

Lead Sponsor

LG Chem
All Listed Sponsors
lead

LG Chem

INDUSTRY

NCT04317703 - Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg. | Biotech Hunter | Biotech Hunter