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Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

Information source: Kowa Research Institute, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Pitavastatin (NK-104) (Drug); Lopinavir/ritonavir (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Kowa Research Institute, Inc.

Official(s) and/or principal investigator(s):
Roger Morgan, MD, FACS, Study Director, Affiliation: Kowa Research Institute, Inc.

Summary

This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Clinical Details

Official title: Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Area Under the Curve From Time 0 to Tau (AUC 0-τ)

Secondary outcome: Adverse Events

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 prior to admission

into the clinical unit. Subjects will check into the clinical unit on Day - 1 for baseline

assessments. There will be one treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through 24. Pitavastatin will be administered under fasting conditions in the morning and lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.

Eligibility

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

Criteria:

Inclusion Criteria:

- 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 for 4 days before Day 1 until after completion of this study.

- Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of

study drug. Exclusion Criteria:

- 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 or

lopinavir/ritonavir.

- 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.

Locations and Contacts

Austin, Texas, United States
Additional Information

Starting date: January 2010
Last updated: July 5, 2012

Page last updated: August 23, 2015

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