Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets

Sponsor
Dexa Medica Group
Study ID
NCT06127212
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin 10 mg film-coated tablet — DRUG
    One tablet of the test drug was given orally (swallowed with 240 mL of 20% glucose solution in water), after an overnight fast.
  • Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia — DRUG
    One tablet of the reference drug was given orally (swallowed with 240 mL of 20% glucose solution in water), after an overnight fast.

Study Details

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.

Key Dates

Start date
Mar 8, 2023
Status verified
Nov 2023
Primary completion
Mar 15, 2023
Completion
May 6, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Test Dapagliflozin Dexa Medica
    Dapagliflozon 10 mg Film-Coated tablet, produced by PT Dexa Medica, Indonesia.
  • Active Comparator: Reference Forxiga AstraZeneca
    Forxiga® 10 mg Film-Coated Tablet, manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Ltd., China imported by PT AstraZeneca Indonesia, Indonesia.

Primary Outcome Measure

AUC(0-t) [ Time Frame: 48 hours ]

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