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NCT00904176 · ClinicalTrials.gov registry record · Phase 1

Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects

A Phase 1 study of Type 2 Diabetes Mellitus, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT00904176 is a Phase 1 study of Type 2 Diabetes Mellitus that has completed, run by AstraZeneca. The registered enrollment target is 30 participants, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00904176, a Phase 1 study of Type 2 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 determine that Dapagliflozin has no effect on the pharmacokinetics (PK) or pharmacodynamics (PD) of warfarin when dapagliflozin is coadministered with warfarin. Also, that Dapagliflozin has no effect on the PK of digoxin when dapagliflozin is coadministered with digoxin.

Conditions Studied

Interventions

  • DRUG Dapagliflozin
  • DRUG Digoxin
  • DRUG Warfarin

Study Locations (1)

Kansas

  • Pra International - Lenexa

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2009-06
Est. Completion 2009-08
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT00904176

The ClinicalTrials.gov registry entry for NCT00904176 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 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Dapagliflozin is the first listed.

NCT00904176 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.

Frequently Asked Questions

What is clinical trial NCT00904176 about?

NCT00904176 is a clinical study titled "Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects". The purpose of this study is determine that Dapagliflozin has no effect on the pharmacokinetics (PK) or pharmacodynamics (PD) of warfarin when dapagliflozin is coadministered with warfarin. Also, that Dapagliflozin has no effect on the PK of digoxin when dapagliflozin is coadministered with digoxin.

What is the current status of trial NCT00904176?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-06. Estimated completion is 2009-08.

What conditions does trial NCT00904176 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT00904176?

The interventions under investigation include: Dapagliflozin (DRUG), Digoxin (DRUG), Warfarin (DRUG).

Who is sponsoring clinical trial NCT00904176?

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

Where is trial NCT00904176 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.