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NCT00839683 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00839683: Completed Phase 1 study, sponsored by AstraZeneca.

NCT00839683 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00839683, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects

Interventions

  • DRUG Dapagliflozin
  • DRUG simvastatin
  • DRUG valsartan

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2009-02
Est. Completion 2009-03
Phase Phase 1
AstraZeneca

1,285 total trials

What the finished NCT00839683 record still lists

NCT00839683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 3 interventions - of which Dapagliflozin is the first listed.

NCT00839683 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00839683 about?

NCT00839683 is a clinical study titled "Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects". Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapag...

What is the current status of trial NCT00839683?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-02. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00839683?

The interventions under investigation include: Dapagliflozin (DRUG), simvastatin (DRUG), valsartan (DRUG).

Who is sponsoring clinical trial NCT00839683?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00839683's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 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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Source: ClinicalTrials.gov NCT00839683, the US trial registry maintained by the National Library of Medicine. NCT00839683 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.