A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers

Sponsor
Janssen-Cilag International NV
Study ID
NCT01877889
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin — DRUG
    One 300 mg over-encapsulated tablet taken orally (by mouth) once daily for 4 days during Part 1 and Part 2 (Sequence 1 \[treatment period 2\] or Sequence 2 \[treatment period 1\]).
  • Dapagliflozin — DRUG
    One 10 mg over-encapsulated tablet taken orally once daily for 4 days during Part 2 (Sequence 1 \[treatment period 1\] or Sequence 2 \[treatment period 2\]).

Study Details

The purpose of this study is to compare the pharmacodynamics (ie, how the drug affects the body) of canagliflozin with the pharmacodynamics of dapagliflozin.

Key Dates

Start date
Jul 31, 2013
Status verified
Mar 2014
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Cana
    Each volunteer will receive 300 mg of canagliflozin once daily for 4 days.
  • Experimental: Part 2: Sequence 1 (Dapa/Cana)
    Each volunteer will receive 10 mg of dapagliflozin once daily for 4 days (treatment period 1) followed by 300 mg of canagliflozin once daily for 4 days (treatment period 2). Each treatment period will be separated by a 12- to 14-day washout period (with no medication).
  • Experimental: Part 2: Sequence 2 (Cana/Dapa)
    Each volunteer will receive 300 mg of canagliflozin once daily for 4 days (treatment period 1) followed by 10 mg of dapagliflozin once daily for 4 days (treatment period 2). Each treatment period will be separated by a 12- to 14-day washout period.

Primary Outcome Measure

Between treatment difference in 24-hour mean renal threshold for glucose for canagliflozin (300 mg once daily for 4 days) compared to dapagliflozin (10 mg once daily for 4 days) [ Time Frame: Day 4 ]

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