Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)

Study identifier:CV181-092

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 1000 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 1000 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Saxagliptin, Metformin IR (glucophage), Saxagliptin + Metformin IR (FDC)

Sex

All

Actual Enrollment

Study type

Interventional

Age

19 Years - 45 Years

Date

Study Start Date: 01 Jun 2009

Primary Completion Date: 01 Jul 2009

Study Completion Date: 01 Jul 2009

Study design

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

Verification:

Verified 01 May 2015 by AstraZeneca Pharmaceuticals

Collaborators

Astra-Zeneca

Inclusion and exclusion criteria

Location

Mds Pharma Services

Lincoln, NE, United States, 68502

Arms	Assigned Interventions
Other: Arm A Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions	Drug: Saxagliptin Tablet, Oral, 2.5 mg, Once Daily, 1 week Other Name: Onglyza Drug: Metformin IR (glucophage) Tablets, Oral, 1000 mg, Once Daily, 1 week Other Name: Glucophage
Other: Arm B Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions	Drug: Saxagliptin + Metformin IR (FDC) Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week Other Name: Onglyza Other Name: Glucophage
Other: Arm C Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal	Drug: Saxagliptin Tablet, Oral, 2.5 mg, Once Daily, 1 week Other Name: Onglyza Drug: Metformin IR (glucophage) Tablets, Oral, 1000 mg, Once Daily, 1 week Other Name: Glucophage
Other: Arm D Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal	Drug: Saxagliptin + Metformin IR (FDC) Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week Other Name: Onglyza Other Name: Glucophage

Documents available

BMS Clinical Trials Disclosure
Download
Investigator Inquiry form
Download
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol-Myers Squibb