Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)

NCT ID: NCT02060201

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-05-31

Brief Summary

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.

Detailed Description

Primary Purpose: This study is designed to demonstrate the bioequivalence of Saxagliptin and Dapagliflozin from a FDC tablet after oral administration relative to Saxagliptin and Dapagliflozin tablets administered orally together in the fasted and fed state

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting

Saxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods

Group Type: OTHER

Saxagliptin

Intervention Type: DRUG

Dapagliflozin

Intervention Type: DRUG

Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fasting

Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Group Type: OTHER

Saxagliptin/Dapagliflozin FDC

Intervention Type: DRUG

Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fed

Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Group Type: OTHER

Saxagliptin/Dapagliflozin FDC

Intervention Type: DRUG

Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting

Saxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods

Group Type: OTHER

Saxagliptin

Intervention Type: DRUG

Dapagliflozin

Intervention Type: DRUG

Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fasting

Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Group Type: OTHER

Saxagliptin/Dapagliflozin FDC

Intervention Type: DRUG

Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fed

Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Group Type: OTHER

Saxagliptin/Dapagliflozin FDC

Intervention Type: DRUG

Interventions

Saxagliptin

Intervention Type: DRUG

Dapagliflozin

Intervention Type: DRUG

Saxagliptin/Dapagliflozin FDC

Intervention Type: DRUG

Other Intervention Names

Onglyza®; BMS-477118; Farxiga®; Forxiga®; BMS-512148; BMS-986098

Eligibility Criteria

Inclusion Criteria

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (PE), vital signs, 12-lead ECG, and clinical laboratory determinations
• Body mass index (BMI) of 18.5 to 30 kg/m(2)
• Men and women, ages 18 to 50 years
• Women of childbearing potential must use acceptable methods of highly effective birth control

Exclusion Criteria

• Any significant acute or chronic medical illness
• Current or recent gastrointestinal disease
• Any major surgery within 4 weeks of study drug administration
• History of chronic or recurrent urinary tract infection for females
• History of glucose intolerance or diabetes mellitus
• History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose cotransporter (SGLT) inhibitors
• Prior exposure to Saxagliptin or Dapagliflozin or related drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

118,840

Identifier Type: OTHER

Identifier Source: secondary_id

CV181-341

Identifier Type: -

Identifier Source: org_study_id