Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01365091
• Date of registration: 16/05/2011
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
• Scientific 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
• Date of first enrolment: June 2011
• Target sample size: 112
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01365091
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Brazil

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Saxagliptin/Metformin FDC

Drug: Saxagliptin/metformin fixed-dose combination (FDC)

Drug: Metformin

Drug: Saxagliptin

Drug: Metformin extended-release (XR)

Primary Outcome(s)

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 [Time Frame: Days 1, 2, and 3 of Periods 1 and 2]

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 [Time Frame: Days 1, 2, and 3 of Periods 1 and 2]

Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets [Time Frame: Days 1, 2, and 3 of Periods 1 and 2]

Secondary Outcome(s)

Number of Participants With Death as Outcome and Serious Adverse Events (SAEs) [Time Frame: Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1]

Secondary ID(s)

CV181-162

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/08/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01365091