Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

Study identifier:MB102-037

ClinicalTrials.gov identifier:NCT00842556

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Dapagliflozin, Glimepiride, Sitagliptin

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Mar 2009

Primary Completion Date: 01 May 2009

Study Completion Date: 01 May 2009

Study design

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

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

Ppd Development

Austin, TX, United States, 78744

Arms	Assigned Interventions
Active Comparator: Dapagliflozin	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148
Active Comparator: Glimepiride	Drug: Glimepiride Tablets, Oral, 4 mg, Single Dose Other Name: Amaryl
Active Comparator: Dapagliflozin + Glimepiride	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 Drug: Glimepiride Tablets, Oral, 4 mg, Single Dose Other Name: Amaryl
Active Comparator: Sitagliptin	Drug: Sitagliptin Tablets, Oral, 100 mg, Single Dose Other Name: Januvia
Active Comparator: Dapagliflozin + Sitagliptin	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 Drug: Sitagliptin Tablets, Oral, 100 mg, Single Dose Other Name: Januvia

"There is no result for the study"

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
MB102-037_Redacted _CSR _synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

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

Investigators

Principal Investigator

Bristol-Myers Squibb

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Ppd Development

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

MB102-037_Redacted _CSR _synopsis

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator