Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State

NCT02223065 | Completed Phase 1 Results

• 1 other identifier: CV181-364
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• Saxagliptin Maximum Observed Concentrations (Cmax)

  5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state

  Day 1-3 (Period 1) and Day 8-10 (Period 2)

• Dapagliflozin Maximum Observed Concentrations (Cmax)

  5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state

  Day 1 to 3 (Period 1) and Day 8 to 10 (Period 2)

• Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])

  5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state

  Day 1-3 (Period 1) and Day 8-10 (Period 2)

• Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])

  5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state

  Day 1-3 (Period 1) and Day 8-10 (Period 2)

• Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])

  5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state

  Day 1-3 (Period 1) and Day 8-10 (Period 2)

• Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])

  5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state

  Day 1-3 (Period 1) and Day 8-10 (Period 2)

Study Arms (2)

Treatment A

EXPERIMENTAL

Single oral dose of saxagliptin tablet coadministered with dapagliflozin tablet

Drug: Saxagliptin; Drug: Dapagliflozin

Treatment B

EXPERIMENTAL

Single oral dose of FDC (fixed-dose combination) tablet

Drug: Saxagliptin; Drug: Dapagliflozin

Interventions

Saxagliptin DRUG

Also known as: Onglyza

Treatment A; Treatment B

Dapagliflozin DRUG

Also known as: Farxiga in the United States, Forxiga in other countries

Treatment A; Treatment B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin; dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Eva Johnsson, Clinical Science Lead, GLOBAL_MEDICINES_DEV
• Organization: AstraZeneca AB, S-151 85 Södertälje, Sweden

Eva.Johnsson@astrazeneca.com

+46 31 7762484

Study Officials

• Michael Gartner, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 22, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 27, 2016
• Results First Posted: April 27, 2016

Record last verified: 2016-03