Drug Interaction With Metformin

Part of paid clinical trials in Hamilton, New Jersey.

Sponsor
AstraZeneca
Study ID
NCT00546741
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Male and Female Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    Tablets, Oral, 20 mg, once daily single dose
  • Metformin — DRUG
    Tablets, Oral, 1000 mg, once daily, single dose
  • Dapagliflozin + Metformin — DRUG
    Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg

Study Details

The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Key Dates

Start date
Nov 30, 2007
Status verified
Dec 2016
Primary completion
Feb 29, 2008
Completion
Feb 29, 2008

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Experimental: 1
  • Active Comparator: 2
  • Active Comparator: 3

Primary Outcome Measure

To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment [ Time Frame: measures taken daily throughout the study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Bristol-Myers Squibb Clinical Pharmacology UnitHamiltonNew Jersey08690-

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By research site
Bristol-Myers Squibb Clinical Pharmacology Unit· Hamilton, NJ

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