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Phase 1 N=36 Randomized Basic Science

Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State

Type 2 Diabetes Mellitus

Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Saxagliptin Maximum Observed Concentrations (Cmax) — 26.2; 25.5 ng/mL — p=0.4950

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Saxagliptin (Drug); Dapagliflozin (Drug)
Age
Adult · 19+ yrs
Sex
All
Sponsor
AstraZeneca
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Saxagliptin Maximum Observed Concentrations (Cmax)
26.2; 25.5 0.4950
PRIMARY
Dapagliflozin Maximum Observed Concentrations (Cmax)
142; 141 0.8650
PRIMARY
Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])
95.9; 98.0 0.2344
PRIMARY
Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])
537; 546 0.2458
PRIMARY
Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
97.0; 99.4 0.1947
PRIMARY
Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
553; 561 0.3191

Summary

The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy subjects.

Eligibility Criteria

Inclusion Criteria

  • Signed Informed Consent Form
  • Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
  • Target Population
  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results.
  • Age and Reproductive Status
  • Males and females, ages 19 to 55 years, inclusive. To extent possible, the distribution of men and women between the sequences will be balanced
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  • Women must not be breastfeeding. d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs saxagliptin and dapagliflozin plus 5 half lives of study drug dapagliflozin (the longer half life between the 2 drugs; 3 days) for a total of 3 days following treatment completion.

e) Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs saxagliptin and dapagliflozin plus 5 half lives of dapagliflozin (the longer half life between the 2 drugs; 3 days) for a total of 3 days following treatment completion.

f) Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section

Exclusion Criteria

  • Any significant acute or chronic medical illness.
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
  • Any other sound medical, psychiatric, and/or social reason as determined by the investigator
  • Any major surgery within 4 weeks of study drug administration.
  • Any prior GI surgery including cholecystectomy (remote history of appendectomy will not be exclusionary).
  • Current, recent (within 3 months of study drug administration), or remote history of pancreatitis.
  • Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 4 weeks before study drug administration.
  • Blood transfusion within 4 weeks of study drug administration. h) Inability to tolerate oral medication.
  • Inability to be venipunctured performed and/or tolerate venous access.
  • Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, e-cigarettes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months before check-in.
  • Drug or alcohol abuse (within 2 years of study drug administration) as defined in the Diagnostic and Statistical Manual of Mental Disorders - 4th Edition, Diagnostic Criteria for Drug and Alcohol Abuse History of glucose intolerance or diabetes mellitus.
  • For females, history of chronic or recurrent urinary tract infection (UTI) (defined as 3 occurrences per year) or UTI in the past 3 months. For males, any UTI within the previous 5 years that has not been thoroughly evaluated and for which an explanation is not clear.
  • History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections.
  • Any other sound medical, psychiatric, and/or social reason as determined by the investigator.

Physical and Laboratory Test Findings

  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population.
  • Abnormal urinalysis at screening (may repeat once). If the urinalysis is abnormal on Day -1
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02223065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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