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NCT01192139 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)
A Phase 1 study of Diabetes Mellitus, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01192139: Completed Phase 1 study of Diabetes Mellitus, sponsored by AstraZeneca.
NCT01192139 is a Phase 1 study of Diabetes Mellitus that has completed, run by AstraZeneca. The registered enrollment target is 30 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192139, a Phase 1 study of Diabetes Mellitus, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana \[IN\]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy subjects.
Primary Outcome
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t \[calculated using the linear trapezoidal rule\] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant
Conditions Studied
Interventions
- DRUG saxagliptin
- DRUG metformin XR
- DRUG saxagliptin + metformin XR (FDC tablet)
Study Locations (1)
Texas
- Ppd Development, Lp - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-11 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
What the finished NCT01192139 record still lists
NCT01192139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which saxagliptin is the first listed.
NCT01192139 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01192139 about?
NCT01192139 is a clinical study titled "Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)". The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana \[IN\]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, ...
What is the current status of trial NCT01192139?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-11. Estimated completion is 2009-12.
What conditions does trial NCT01192139 study?
This clinical trial studies the following conditions: Diabetes Mellitus.
What interventions are being tested in trial NCT01192139?
The interventions under investigation include: saxagliptin (DRUG), metformin XR (DRUG), saxagliptin + metformin XR (FDC tablet) (DRUG).
Who is sponsoring clinical trial NCT01192139?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01192139 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01192139's enrollment target sits among peer trials
30 177th of 208 higher than 29 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus 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.
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