Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

Study of Bioavailability of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034565
• Other study ID #: CV185-029
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2014
• Last updated: March 28, 2016
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: January 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban Phase 3 tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

• Any significant acute or chronic medical illness or relevant trauma (e.g., history of chronic hypertension, bacterial endocarditis, hemorrhagic stroke, motor vehicle accident resulting in significant head trauma or internal injuries)

• History or evidence of abnormal bleeding or coagulation disorder (e.g., easy bruising or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after trauma, wounds or surgery)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
United States	Mds Pharma Services	Neptune	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of Apixaban solution formulation relative to Apixaban Phase 3 tablets in healthy subjects		Up to 8 Days	No
Secondary	Maximum observed plasma concentration (Cmax) of Apixaban obtained from the plasma concentration versus time data		32 timepoints up to Day 8	No
Secondary	Time of maximum observed plasma concentration (Tmax) of Apixaban obtained from the plasma concentration versus time data		32 timepoints up to Day 8	No
Secondary	Area under the plasma concentration-time curve from time zero to the time of last quantifiable plasma concentration [AUC (0-T)] of Apixaban obtained from the plasma concentration versus time data		32 timepoints up to Day 8	No
Secondary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC (INF)] of Apixaban obtained from the plasma concentration versus time data		32 timepoints up to Day 8	No
Secondary	Plasma elimination half-life (T-Half) of Apixaban obtained from the plasma concentration versus time data		32 timepoints up to Day 8	No
Secondary	Safety analysis based on the Adverse events reports, Vital sign measurements, Electro cardiogram (ECG), physical examinations, and clinical laboratory tests		Up to Day 8	Yes

External Links

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