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Completed

NCT Number: NCT02060201

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saxagliptin

Drug

Other names: Onglyza®, BMS-477118

Dapagliflozin

Drug

Other names: Farxiga®, Forxiga®, BMS-512148

Saxagliptin/Dapagliflozin FDC

Drug

Other names: BMS-986098

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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