A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers

Part of paid clinical trials in Neptune City, New Jersey.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01756417
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin — DRUG
    One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8.
  • Canagliflozin (JNJ-28431754) — DRUG
    Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8.

Study Details

The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed.

Key Dates

Start date
Oct 31, 2007
Status verified
Jun 2016
Primary completion
Nov 30, 2007
Completion
Nov 30, 2007

Study Design

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

Arms

  • Experimental: Metformin + canagliflozin (JNJ-28431754)
    Each volunteer will receive a single dose of metformin on Day 1 followed by canagliflozin (JNJ-28431754) once daily on Days 4 to 7. On Day 8, volunteers will receive a single dose of canagliflozin in combination with a single dose of metformin.

Primary Outcome Measure

The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754) [ Time Frame: Up to Day 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-Neptune CityNew Jersey--

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