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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01192139
The ClinicalTrials.gov registry entry for NCT01192139 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (98% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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