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A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers

NCT01707316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-02-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will also be assessed.

Conditions

  • Healthy

Interventions

DRUG

Treatment A: Canagliflozin 100 mg

Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.

DRUG

Treatment B: Canagliflozin 300 mg

Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.

OTHER

Treatment C: Placebo

Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • China

Study Locations

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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 NCT01707316 on ClinicalTrials.gov