Status:
COMPLETED
Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug interaction study.
Detailed Description
This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study. Each subject will qualify for entry into the study not more than 30 days before admission into the cli...
Eligibility Criteria
Inclusion
- Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
- Subject has a body mass index of 18 to 30 kg/m2, inclusive.
- Subject has normal hematology, serum chemistry, and urinalysis test results
- Subject is able and willing to abstain from alcohol, grapefruit, caffeine or caffeine containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until completion of the study
- Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until study completion.
Exclusion
- Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
- Subject has had a previous allergy or intolerance to treatment with pitavastatin, darunavir, ritonavir, sulfonamides, or any drugs in these classes.
- Subject has a history of drug or alcohol abuse.
- Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01422369
Start Date
April 1 2011
End Date
June 1 2011
Last Update
July 13 2012
Active Locations (1)
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1
Austin, Texas, United States