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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: Completed Phase 1 study, sponsored by AstraZeneca.
NCT03169959 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess pharmacokinetics (PK) in terms of AUC in Cohort 1 after administration of Treatment A, B (under fed condition), C (under fasted condition) and Cohort 2 after administration of Treatment D, E (under fed condition) and F (under fasted condition) in healthy volunteers.
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 |
What the finished NCT03169959 record still lists
NCT03169959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 5 interventions - of which 2.5 mg Saxagliptin tablet is the first listed.
NCT03169959 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03169959's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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