Clinical trial NCT01365091: Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
Official title: Bioequivalence Study of Fixed Dose Combinations of Saxagliptin/Metformin Extended Release (XR) Relative to Co-administration of the Individual Components in Healthy Subjects in the Fasted and Fed States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.


Eligibility criteria: Key Inclusion Criteria:

* Healthy men and women
* women of childbearing potential who are using acceptable method of contraception
* Women who are not pregnant or nursing
* Body Mass Index (BMI) of 18 to 29.9 kg/m\^2, inclusive. BMI=weight(kg)/height(m)\^2.

Key Exclusion Criteria:

* Any significant acute or chronic medical illness.
* History of gastrointestinal (GI) disease
* Major surgery within 4 weeks of study drug administration
* Any GI surgery that could impact study drug absorption
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.
* Blood transfusion within 3 months of study drug administration for women and within 2 months for men
* Inability to be venipunctured and/or tolerate venous access
* Current smoker or recent (within 1 month) history of regular tobacco use
* Recent (within 6 months of study drug administration) drug or alcohol abuse
* Participation in a bioequivalence study within the last 6 months of study drug administration
* Estimated creatinine clearance of \<80 mL/min using Cockcroft-Gault formula
* History of allergy to drug class or related compounds
* History of allergy to metformin or other similar acting agents
* History of any significant drug allergy

Primary outcomes:
measure: Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
timeFrame: Days 1, 2, and 3 of Periods 1 and 2
measure: AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
timeFrame: Days 1, 2, and 3 of Periods 1 and 2
measure: AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets
timeFrame: Days 1, 2, and 3 of Periods 1 and 2
Secondary outcomes:
measure: Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)
timeFrame: Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: