A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01294631
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin 300 mg once daily and HCTZ 25 mg once daily — DRUG
    Period 1: canagliflozin tablets, oral, 300 mg, once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets, oral, 25 mg, once daily for Days 1 to 28 followed by canagliflozin tablets, oral, 300 mg, once daily taken with HCTZ tablets, oral 25 mg, once daily on Days 29 to 35..

Study Details

The purpose of the study is to evaluate the effects of multiple doses of hydrochlorothiazide and canagliflozin on the concentrations of each drug in the blood and the concentration of glucose in the blood and urine in healthy adult volunteers.

Key Dates

Start date
Mar 31, 2011
Status verified
Oct 2012
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    Canagliflozin 300 mg once daily and HCTZ 25 mg once daily Period 1: canagliflozin tablets oral 300 mg once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets oral 25 mg once daily for Days 1 to 28 followed by canagliflozin tablets oral 300 mg once daily taken with HCTZ tablets oral 25 mg once daily on Days 29 to 35..

Primary Outcome Measure

Urine glucose concentration [ Time Frame: At protocol-specified time points up to Day 36 in Period 2 ]

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