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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 35 participants.

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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

FieldValue
Enrollment Target 35 participants
Start Date 2010-05
Est. Completion 2010-06
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT01135446

The ClinicalTrials.gov registry entry for NCT01135446 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which dapagliflozin is the first listed.

NCT01135446 reports 0 study locations.

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.

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

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.