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Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: N/A - Healthy Subjects

Intervention: Apixaban (Drug); Atenolol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.

Clinical Details

Official title: Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Apixaban and Atenolol plasma concentration

Secondary outcome: Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy subjects as determined by no clinically significant deviation from normal in

medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations Exclusion Criteria:

- Any significant acute or chronic medical illness, history of hypotension, history or

evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years

Locations and Contacts

Bms Clinical Research Center, Hamilton, New Jersey 08690, United States
Additional Information

Starting date: June 2007
Last updated: August 6, 2015

Page last updated: August 23, 2015

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