Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)

Sponsor
AstraZeneca
Study ID
NCT02060201
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.

Key Dates

Start date
Feb 28, 2014
Status verified
Jun 2015
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Other: Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting
    Saxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods
  • Other: Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fasting
    Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
  • Other: Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fed
    Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
  • Other: Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting
    Saxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods
  • Other: Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fasting
    Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
  • Other: Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fed
    Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin [ Time Frame: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days ]

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