A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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

Detailed description: 
      The study will be conducted as a 2-part study. Part 1 is an open-label pilot study (the
      investigator and the participants know the identity of the assigned treatment) in which 6
      healthy volunteers will be given 300 mg of canagliflozin once daily for 4 consecutive days.
      The total study duration for each volunteer in Part 1 will be approximately 35 days
      (including a screening phase, an open-label treatment phase, and a follow-up phase). Part 2
      will be a double-blind (neither the investigator nor volunteers know the identity of the
      assigned treatment), randomized (the treatment is assigned by chance), 2-period crossover
      study (all volunteers will receive each of the 2 treatments but in a different order) with a
      two-stage sequential group design.

      Approximately 34 healthy volunteers will be participating in the first stage. After all the
      participants of the first stage will complete Part 2, and the results are analyzed, based on
      the first stage outcomes the study will be either terminated or will proceed to the second
      stage, which will be conducted using the same study method as in the first stage.

      Potentially, up to 30 volunteers will participate in the second stage. A total number of
      participants in Part 2 will be up to 64.

      Volunteers assigned to Treatment Sequence 1 will receive 10 mg of dapagliflozin once daily
      for 4 consecutive days (Period 1), and after a 12- to 14-day washout period (with no
      medication), 300 mg of canagliflozin once daily for 4 days (Period 2). Volunteers assigned to
      Treatment Sequence 2 will receive 300 mg of canagliflozin once daily for 4 days (Period 1),
      and after a 12- to 14-day washout period, 10 mg of dapagliflozin once daily for 4 consecutive
      days (Period 2). The total study duration for each volunteer in Part 2 will be up to
      approximately 65 days (including a screening phase, a baseline phase, a double-blind
      treatment phase, a washout period, and a follow-up phase).

      Volunteers can participate in Part 1 or Part 2 of the study, but not in both parts.
      Canagliflozin and dapagliflozin are used for the treatment of type 2 diabetes mellitus.
    

Intervention name(s): Canagliflozin; Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): 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]).; 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]).
Other intervention name(s): Invokana; Forxiga
Intervention MeSH terms: Dapagliflozin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin; INVOKANA; Dapagliflozin; FORXIGA; Pharmacodynamics