Status:
COMPLETED
Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy subjects.
Eligibility Criteria
Inclusion
- 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
- 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 of Period 1, continuation in the study is up to the investigator's discretion. The CRO medical monitor should be consulted.
- Glucosuria or hematoria at screening or Day -1 of Period 1, repeat is not permitted. d) A positive nicotine test (ie, cotinine).
- e) Abnormal liver function tests (alanine or aspartate aminotransferase \[ALT or AST, respectively\], or total bilirubin).
- f) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
- i) PR ≥ 210 ms ii) QRS ≥ 120 ms iii) QT ≥ 500 ms iv) QTcF ≥ 450 ms g) Positive urine screen for drugs of abuse. h) Positive urine alcohol test. i) Positive blood screen for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at screening.
- Allergies and Adverse Drug Reaction
- History of allergy or adverse reactions to DPP4 or SGLT inhibitors or related compounds.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
- Other Exclusion Criteria
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Inability to comply with restrictions and prohibited activities/treatments
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02223065
Start Date
September 1 2014
End Date
December 1 2014
Last Update
April 27 2016
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