Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
AstraZeneca
Study ID
NCT01662999
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when they are administered together

Key Dates

Start date
Aug 31, 2012
Status verified
Apr 2015
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Experimental: A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)
    Treatment A: Saxagliptin 5mg, Tablet, Oral; Single dose Treatment B: Dapagliflozin 10mg, Tablet, Oral; single dose Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; single dose
  • Experimental: A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin
    Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose
  • Experimental: B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)
    Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose. Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose
  • Experimental: B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin
    Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose
  • Experimental: C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin
    Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose
  • Experimental: C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin
    Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, Once daily, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population [ Time Frame: Day 1 (0 h to 60 h post dose) in each period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icon Clinical PharmacologyOmahaNebraska68154-

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