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NCT01135446 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01135446: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01135446 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01135446, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.
Interventions
- DRUG dapagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT01135446 record still lists
NCT01135446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which dapagliflozin is the first listed.
NCT01135446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01135446 about?
NCT01135446 is a clinical study titled "Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects". The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.
What is the current status of trial NCT01135446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2010-05. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01135446?
The interventions under investigation include: dapagliflozin (DRUG).
Who is sponsoring clinical trial NCT01135446?
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 NCT01135446's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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