Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 4:57 AM
Study NCT ID:
NCT05266404
Status:
COMPLETED
Last Update Posted:
2022-07-05
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Randomized, 2-period, 2-treatment, Single-dose, Crossover Study to Assess the Bioequivalence of the Fixed Dose Combination (FDC) of Dapagliflozin 10 mg and Sitagliptin 100 mg, and Dapagliflozin 10 mg and Sitagliptin 100 mg Administered as Individual Tablets in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-06
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:
A Study to Assess the Bioequivalence of the fixed dose combination (FDC) of Dapagliflozin and Sitagliptin, and Dapagliflozin 10 mg and Sitagliptin 100 mg administered as individual tablets in Healthy Subject
Detailed Description:
This study will be a randomized, open-label, 2-period, 2-treatment, single-dose, crossover study in healthy subjects (males and females), performed at a single study center. The study will assess the bioequivalence between a dapagliflozin/sitagliptin FDC tablet (test formulation) and a free combination of dapagliflozin 10 mg + sitagliptin 100 mg co-administered as individual tablets (reference formulation) in fasted conditions to healthy subjects. The study will also assess the Pharmacokinetics (PK) and safety and tolerability of dapagliflozin 10 mg and sitagliptin 100 mg when co-administered as individual tablets and as an FDC tablet.
The study will comprise:
* A Screening Period of maximum 28 days.
* Two Treatment Periods (Treatment A or B)
* A final Safety Follow-up Visit 7 to 14 days after the last dosing with the Investigational medicinal product (IMP) (Treatment A or B).
There will be a minimum washout period of 7 days and a maximum of 14 days between each treatment period.
All subjects will receive a single dose of the following treatments after an overnight fast of 10 hours:
* Treatment A: 1 × dapagliflozin/sitagliptin FDC tablet (test formulation).
* Treatment B: 1 × dapagliflozin 10 mg tablet + 1 × sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation).
Subjects will be randomized to one of 2 treatment sequences: Treatment A followed by Treatment B or Treatment B followed by Treatment A.
The study will comprise:
* A Screening Period of maximum 28 days.
* Two Treatment Periods (Treatment A or B)
* A final Safety Follow-up Visit 7 to 14 days after the last dosing with the Investigational medicinal product (IMP) (Treatment A or B).
There will be a minimum washout period of 7 days and a maximum of 14 days between each treatment period.
All subjects will receive a single dose of the following treatments after an overnight fast of 10 hours:
* Treatment A: 1 × dapagliflozin/sitagliptin FDC tablet (test formulation).
* Treatment B: 1 × dapagliflozin 10 mg tablet + 1 × sitagliptin 100 mg tablet co-administered as individual tablets (reference formulation).
Subjects will be randomized to one of 2 treatment sequences: Treatment A followed by Treatment B or Treatment B followed by Treatment A.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-005104-35 | EUDRACT_NUMBER | None | View |