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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Bioequivalence Study of 2.5-mg Saxagliptin/5-mg Dapagliflozin and 5-mg Saxagliptin/10-mg Dapagliflozin Fixed Dose Combination Tablets Relative to Coadministration of Their Respective Individual Components in Healthy Subjects and a Characterization of the Effect of Food on the Fixed Dose Combination Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060201
• Other study ID #: CV181-341
• Secondary ID: 118,840
• Status: Completed
• Phase: Phase 1
• First received: February 10, 2014
• Last updated: June 9, 2015
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

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

• Dapagliflozin

• Saxagliptin/Dapagliflozin FDC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin		54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Primary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)] for Saxagliptin and Dapagliflozin		54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Primary	Area under the concentration-time curve from time zero extrapolated to infinite time [(AUC(INF)] for Saxagliptin and Dapagliflozin		54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Secondary	Cmax for 5-hydroxy (OH) Saxagliptin		54 time points up to 15 days	No
Secondary	AUC(0-T) for 5-hydroxy (OH) Saxagliptin		54 time points up to 15 days	No
Secondary	AUC(INF) for 5-hydroxy (OH) Saxagliptin		54 time points up to 15 days	No
Secondary	Time of maximum observed plasma concentration (Tmax) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin		54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Secondary	Percent of AUC extrapolated from last quantifiable concentration to infinity (pAUCe) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin		54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Secondary	Half life (T HALF) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin		54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Secondary	Terminal disposition rate constant (Lambda) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin		54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Secondary	Time point where log-linear elimination begins (TLIN) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin		54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Secondary	Time at which the last concentration occurred that is above the lower limit of quantitation (LQCT) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin		54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days	No
Secondary	Safety measured by the occurrence of deaths, adverse events (AEs), serious adverse events (SAEs), results of clinical laboratory tests, vital sign measurements, physical examination findings, and 12-lead electrocardiogram (ECG) results		Approximately up to 16 days	Yes