Pharmacokinetics of Plasma Lopinavir/Ritonavir Over a 12 Hour Dosing Interval Following Administration of 400/100, 200/150, and 200/50 mg Twice Daily to HIV-negative Healthy Volunteers (ENCORE3)

NCT00985543 Phase 1 COMPLETED Results posted

The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval, following administration to male and female HIV-negative healthy volunteers of: 1. Lopinavir/ritonavir 400/100 mg twice daily 2. Lopinavir/ritonavir 200/150 mg twice daily 3. Lopinavir/ritonavir 200/50 mg twice daily

Details

Lead sponsor	Kirby Institute
Phase	Phase 1
Status	COMPLETED
Enrolment	22
Start date	2009-10
Completion	2010-01

Conditions

• Acquired Immunodeficiency Syndrome

Interventions

• lopinavir/ritonavir

Primary outcomes

• Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h). — at the end of each 7-day dosing phase
  Pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval following administration of lopinavir/ritonavir 400/100mg, 200/150mg and 200/50mg twice daily.

Countries

United Kingdom