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Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets

NCT06127212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-13

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • PT Equilab International

    collaborator INDUSTRY

  • Dexa Medica Group

    lead INDUSTRY

Principal Investigators

  • Danang A Yunaidi, MD · Equilab International

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-08
Primary Completion
2023-03-15
Completion
2023-05-06

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127212 on ClinicalTrials.gov