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PK Study of Dapagliflozin in Pediatric Subjects With T2DM

NCT01525238 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-05-30

Study results available
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Summary

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

Conditions

Interventions

DRUG

Dapagliflozin

Tablet, Oral, 2.5 mg, Single-dose

DRUG

Dapagliflozin

Tablet, Oral, 5 mg, Single-dose

DRUG

Dapagliflozin

Tablet, Oral, 10 mg, Single-dose

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-01
Primary Completion
2014-09-01
Completion
2014-09-01

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

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 NCT01525238 on ClinicalTrials.gov