Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets
Status:
Completed
Trial end date:
2023-05-06
Target enrollment:
Participant gender:
Summary
The study was an open-label, randomized, single-dose, two-period, two-sequence, two-day
crossover study, conducted to find out whether the dapagliflozin 10 mg film-coated tablet
produced by PT Dexa Medica (test drug) was bioequivalent to the reference 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), under
fasting condition with a five days wash-out period, involving 24 healthy adult male and
female subjects.