Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
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ClinicalTrials.gov Identifier: NCT02060201 |
Recruitment Status :
Completed
First Posted : February 11, 2014
Last Update Posted : June 10, 2015
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes Mellitus | Drug: Saxagliptin Drug: Dapagliflozin Drug: Saxagliptin/Dapagliflozin FDC | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
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 |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
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
|
Drug: Saxagliptin
Other Names:
Drug: Dapagliflozin Other Names:
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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
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Drug: Saxagliptin/Dapagliflozin FDC
Other Name: BMS-986098 |
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
|
Drug: Saxagliptin/Dapagliflozin FDC
Other Name: BMS-986098 |
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
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Drug: Saxagliptin
Other Names:
Drug: Dapagliflozin Other Names:
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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
|
Drug: Saxagliptin/Dapagliflozin FDC
Other Name: BMS-986098 |
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
|
Drug: Saxagliptin/Dapagliflozin FDC
Other Name: BMS-986098 |
- 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 ]
- 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 ]
- Cmax for 5-hydroxy (OH) Saxagliptin [ Time Frame: 54 time points up to 15 days ]
- AUC(0-T) for 5-hydroxy (OH) Saxagliptin [ Time Frame: 54 time points up to 15 days ]
- AUC(INF) 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060201
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT02060201 |
Other Study ID Numbers: |
CV181-341 118,840 ( Other Identifier: IND Number ) |
First Posted: | February 11, 2014 Key Record Dates |
Last Update Posted: | June 10, 2015 |
Last Verified: | June 2015 |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Dapagliflozin Saxagliptin Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action |
Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors |