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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	29 June 2015
Main ID:	NCT02060201
Date of registration:	10/02/2014
Prospective Registration:	No
Primary sponsor:	AstraZeneca
Public title:	Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
Scientific 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
Date of first enrolment:	February 2014
Target sample size:	72
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT02060201
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Phase:	Phase 1

Countries of recruitment

Contacts

Name:	Bristol-Myers Squibb
Address:
Telephone:
Email:
Affiliation:	Bristol-Myers Squibb

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Saxagliptin/Dapagliflozin FDC

Drug: Saxagliptin

Drug: Dapagliflozin

Primary Outcome(s)

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [(AUC(0-T)] for Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

Area under the concentration-time curve from time zero extrapolated to infinite time [(AUC(INF)] for Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

Secondary Outcome(s)

AUC(INF) for 5-hydroxy (OH) Saxagliptin [Time Frame: 54 time points up to 15 days]

Cmax for 5-hydroxy (OH) Saxagliptin [Time Frame: 54 time points up to 15 days]

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 [Time Frame: Approximately up to 16 days]

Time point where log-linear elimination begins (TLIN) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

Half life (T HALF) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

Time at which the last concentration occurred that is above the lower limit of quantitation (LQCT) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

Terminal disposition rate constant (Lambda) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

Percent of AUC extrapolated from last quantifiable concentration to infinity (pAUCe) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

AUC(0-T) for 5-hydroxy (OH) Saxagliptin [Time Frame: 54 time points up to 15 days]

Time of maximum observed plasma concentration (Tmax) for Saxagliptin, 5-OH Saxagliptin and Dapagliflozin [Time Frame: 54 time points for Saxagliptin, 5-OH Saxagliptin and 42 time points for Dapagliflozin up to 15 days]

Secondary ID(s)

CV181-341

118,840

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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