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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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Saxagliptin Drug: Dapagliflozin Drug: Saxagliptin/Dapagliflozin FDC Phase 1

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

Study Design
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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

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Arms and Interventions
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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:
  • Onglyza®
  • BMS-477118

Drug: Dapagliflozin
Other Names:
  • Farxiga®
  • Forxiga®
  • BMS-512148
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
 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
 Drug: Saxagliptin
Other Names:
  • Onglyza®
  • BMS-477118

Drug: Dapagliflozin
Other Names:
  • Farxiga®
  • Forxiga®
  • BMS-512148
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Cmax for 5-hydroxy (OH) Saxagliptin [ Time Frame: 54 time points up to 15 days ]
  2. AUC(0-T) for 5-hydroxy (OH) Saxagliptin [ Time Frame: 54 time points up to 15 days ]
  3. AUC(INF) for 5-hydroxy (OH) Saxagliptin [ Time Frame: 54 time points up to 15 days ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02060201     History of Changes
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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
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