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NCT03169959 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT03169959 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 85 participants.
The verdict
NCT03169959, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
A Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product (FCDP) of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin /10 mg Dapagliflozin /1000 mg Metformin XR Relative to Individual Components (Onglyza and XIGDUO XR) Co-administration. A randomized, open-label, cross over design has been chosen to minimize the effects of between-subject variability and any period effects on the overall results.
Interventions
- DRUG 2.5 mg Saxagliptin tablet
- DRUG 5 mg dapagliflozin / 1000 mg metformin XR tablet
- DRUG Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR
- DRUG 5 mg saxagliptin
- DRUG 10 mg dapagliflozin / 1000 mg metformin XR tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2017-05-29 |
| Est. Completion | 2017-08-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03169959
The ClinicalTrials.gov registry entry for NCT03169959 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which 2.5 mg Saxagliptin tablet is the first listed.
NCT03169959 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03169959 about?
NCT03169959 is a clinical study titled "A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.". A Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product (FCDP) of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin /10 mg Dapagliflozin /1000 mg Metformin XR Relative to Individual Components (Onglyza and XIGDUO XR) Co-administrati...
What is the current status of trial NCT03169959?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2017-05-29. Estimated completion is 2017-08-03.
What interventions are being tested in trial NCT03169959?
The interventions under investigation include: 2.5 mg Saxagliptin tablet (DRUG), 5 mg dapagliflozin / 1000 mg metformin XR tablet (DRUG), Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR (DRUG), 5 mg saxagliptin (DRUG), 10 mg dapagliflozin / 1000 mg metformin XR tablet (DRUG).
Who is sponsoring clinical trial NCT03169959?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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