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Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets

Healthy Clinical Trial

Official title:
Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator 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)

Clinical Trial 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.

Clinical Trial Description

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. The participating subjects had an overnight fast and in the next morning were given orally either one film-coated tablet of the test drug or one film-coated tablet of the reference drug with a total 240 mL of a 20% glucose solution in water. Following drug administration, 60 mL of 20% glucose solution was administered at every 15 minutes for up to 4 hours after dosing as maintenance to prevent hypoglycemic symptoms. Blood samples were drawn before taking the drug (control) and at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50,1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 36.00 and 48.00 hours after drug administration. The blood samples were analyzed to investigate the pharmacokinetics parameters of the single dose administration of dapagliflozin. The plasma concentrations of dapagliflozin were determined by using a validated ultra-performance liquid chromatography with tandem mass spectroscopy detection (UPLC-MS/MS). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06127212
Study type Interventional
Source Dexa Medica Group
Contact
Status Completed
Phase N/A
Start date March 8, 2023
Completion date May 6, 2023
View Details
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