Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT06127212
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablets
Sponsor:
Dexa Medica Group
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: