A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott
• Treatments: Lopinavir; Rifabutin; Ritonavir

Criteria

Inclusion Criteria:

• Adult Male or Female 18-55 yrs.

• Subject has provided written consent.

• Subject is in general good health.

• If female, subject is postmenopausal.

• If female, subject is not pregnant and is not breast-feeding.

• Subject must use birth control methods or be surgically sterile.

Exclusion Criteria:

• Subject is HAV-IgM, HBsAg or HIV Ab positive.

• Positive screen for drugs of abuse, alcohol, or smoking.

• Cannot be on any medication, including over the counter drugs.

• Cannot have previous history of alcohol or drug abuse.

• Cannot have history of any major diseases or disorders.