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Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects

NCT01135446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-10-17

No results posted yet for this 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.

Conditions

Interventions

DRUG

dapagliflozin

Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days

DRUG

dapagliflozin

Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days

DRUG

dapagliflozin

Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days

DRUG

dapagliflozin

Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days

DRUG

dapagliflozin

Tablets, Oral, 1 mg, once on Day 1 only, 2 days

DRUG

dapagliflozin

Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135446 on ClinicalTrials.gov