Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 8, 2023

Primary Completion Date

March 15, 2023

Study Completion Date

May 6, 2023

Conditions
Healthy
Interventions
DRUG

Dapagliflozin 10 mg film-coated tablet

One tablet of the test drug was given orally (swallowed with 240 mL of 20% glucose solution in water), after an overnight fast.

DRUG

Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia

One tablet of the reference drug was given orally (swallowed with 240 mL of 20% glucose solution in water), after an overnight fast.

Trial Locations (1)

12430

PT Equilab International, Jakarta

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PT Equilab International

INDUSTRY

lead

Dexa Medica Group

INDUSTRY

NCT06127212 - Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets | Biotech Hunter | Biotech Hunter