Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets

NCT06127212 | Completed

• 1 other identifier: BE. 754/EQL/2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• AUC(0-t)

  Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t

  48 hours

• Cmax

  Maximum plasma concentration

  48 hours

Secondary Outcomes (3)

• AUC(0-inf)

  48 hours

• T1/2

  48 hours

• Tmax

  48 hours

Study Arms (2)

Test Dapagliflozin Dexa Medica

EXPERIMENTAL

Dapagliflozon 10 mg Film-Coated tablet, produced by PT Dexa Medica, Indonesia.

Drug: Dapagliflozin 10 mg film-coated tablet

Reference Forxiga AstraZeneca

ACTIVE COMPARATOR

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

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.

Also known as: Test

Test Dapagliflozin Dexa Medica

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.

Also known as: Reference

Reference Forxiga AstraZeneca

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
• Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation.
• Aged 18 - 55 years inclusive.
• Preferably non-smokers or smoke less than 10 cigarettes per day.
• Body mass index within 18 to 25 kg/m2
• Vital signs (after 10 minutes rest) must be within the following ranges:
• Systolic blood pressure: 100 - 129 mmHg
• Diastolic blood pressure: 60 - 84 mmHg
• Pulse rate: 60 - 90 bpm.
• Willing to practice abstention or contraception during the study

You may not qualify if:

• History of allergy or hypersensitivity or contraindication to dapagliflozin or allied drugs.
• Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug).
• Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
• Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration \> 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
• Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
• Positive result for COVID-19 rapid antigen test.
• Clinically significant hematology abnormalities.
• Clinically significant electrocardiogram (ECG) abnormalities.
• Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery.
• Past history of anaphylaxis or angioedema.
• History of drug or alcohol abuse within 12 months prior to screening for this study.
• Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day.
• History of any bleeding or coagulative disorders.
• Presence of difficulty in accessibility of veins in left or right arm.
• A donation or significant blood loss within 90 days before this study's first dosing day.

Sponsors & Collaborators

• Dexa Medica Group: lead
• PT Equilab International: collaborator

Study Sites (1)

PT Equilab International

Jakarta, 12430, Indonesia

Location

MeSH Terms

Interventions

dapagliflozin

Study Officials

• Danang A Yunaidi, MD

  Equilab International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a bioequivalence study.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: March 8, 2023
• Primary Completion: March 15, 2023
• Study Completion: May 6, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

ID (1)