Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State

Part of paid clinical trials in Austin, Texas.

Sponsor
AstraZeneca
Study ID
NCT01002807
Phase
PHASE1
Status
Completed

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 10 mg, Single Dose
  • Metformin XR — DRUG
    Tablets, Oral, 1000 mg, Single Dose
  • Glucophage — DRUG
    Tablets, Oral, 1000 mg, Single Dose

Study Details

To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.

Key Dates

Start date
Nov 30, 2009
Status verified
Oct 2016
Primary completion
Dec 31, 2009
Completion
Jan 31, 2010

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Other: FDC of dapagliflozin/metformin XR
  • Other: FDC of dapagliflozin/reduced mass metformin XR
  • Other: dapagliflozin and Glucophage® XR

Primary Outcome Measure

Blood samples to measure the pharmacokinetic parameters Cmax and AUC for the combination products versus each investigational product alone [ Time Frame: 48 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ppd Development, LpAustinTexas78744-

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Ppd Development, Lp· Austin, TX

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