Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
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
2 other identifiers
interventional
72
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes-mellitus
Started Feb 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 10, 2015
June 1, 2015
3 months
February 10, 2014
June 9, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax) for Saxagliptin and Dapagliflozin
54 time points for Saxagliptin and 42 time points for Dapagliflozin up to 15 days
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
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
Secondary Outcomes (10)
Cmax for 5-hydroxy (OH) Saxagliptin
54 time points up to 15 days
AUC(0-T) for 5-hydroxy (OH) Saxagliptin
54 time points up to 15 days
AUC(INF) for 5-hydroxy (OH) Saxagliptin
54 time points up to 15 days
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
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
- +5 more secondary outcomes
Study Arms (6)
Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting
OTHERSaxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods
Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fasting
OTHERSaxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fed
OTHERSaxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting
OTHERSaxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods
Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fasting
OTHERSaxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fed
OTHERSaxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2014
First Posted
February 11, 2014
Study Start
February 1, 2014
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 10, 2015
Record last verified: 2015-06