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Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) (Drug); Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) (Drug); Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) (Drug); Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

To demonstrate the bioequivalence of a 2. 5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2. 5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.

Clinical Details

Official title: Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States

Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States

Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States

Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States

AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States

AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States

AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States

Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States

Secondary outcome:

Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation

Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results

Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women, aged 18 to 55 years, inclusive

- Healthy participants as determined by a lack of clinically significant deviation from

normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations

- Body Mass Index of 18 to 32 kg/m^2, inclusive

Exclusion Criteria:

- Any significant acute or chronic medical illness

- Current or recent (within 3 months) gastrointestinal disease

- Any major surgery within 4 weeks of study drug administration

- History of allergy to DPP-4 inhibitors or related compounds

- History of allergy or intolerance to metformin or other similar acting agents

- Previous exposure to saxagliptin

- Exposure to metformin within 3 months pervious to study drug administration

- Estimated creatinine clearance of <80 mL/min using the Cockcroft Gault formula

Locations and Contacts

Ppd Development, Lp, Austin, Texas 78744, United States
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

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

Starting date: March 2010
Last updated: April 22, 2015

Page last updated: August 23, 2015

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