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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365091
• Other study ID #: CV181-162
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2011
• Last updated: April 21, 2015
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Saxagliptin/metformin fixed-dose combination (FDC)
Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
• Saxagliptin
Tablet, oral, 5 mg, once on Day 1 only, 1 day
• Metformin extended-release (XR)
Tablet, oral, 500 mg, once on Day 1 only, 1 day
• Saxagliptin/Metformin FDC
Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
• Metformin
Tablet, oral, 1000 mg, once on Day 1 only, 1 day

Locations

Country	Name	City	State
Brazil	Local Institution	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets		Days 1, 2, and 3 of Periods 1 and 2	No
Primary	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	AUC=Area under the concentration-time curve	Days 1, 2, and 3 of Periods 1 and 2	No
Primary	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	AUC=Area Under the Concentration-time Curve	Days 1, 2, and 3 of Periods 1 and 2	No
Secondary	Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)	SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.	Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1	Yes

External Links

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