Drug Interaction with Metformin

Study identifier:MB102-026

ClinicalTrials.gov identifier:NCT00546741

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Pharmacokinetic Drug Interaction Study with Dapagliflozin and Metformin in Healthy Subjects

Medical condition

healthy male and female subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Dapagliflozin, Metformin, Dapagliflozin + Metformin

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Nov 2007

Primary Completion Date: 01 Feb 2008

Study Completion Date: 01 Feb 2008

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Dec 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1	Drug: Dapagliflozin Tablets, Oral, 20 mg, once daily single dose
Active Comparator: 2	Drug: Metformin Tablets, Oral, 1000 mg, once daily, single dose
Active Comparator: 3	Drug: Dapagliflozin + Metformin Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg

Documents available

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Download
MB102026 _Redacted _CSR _synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

First line of email MUST contain NCT# & Site#. Only trial are recruiting have contact information at this time.

Investigators

Principal Investigator