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A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus

NCT01128985 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2013-05-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics (blood levels of the drug) and pharmacodynamics (effects of the drug on the body) of canagliflozin after oral administration to patients with type 2 diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Canagliflozin 50 mg

50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7

DRUG

Canagliflozin 100 mg

100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7

DRUG

Canagliflozin 300 mg

300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.

DRUG

Placebo

matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01128985 on ClinicalTrials.gov