Overview
Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)
Status:
Completed
Completed
Trial end date:
2009-02-01
2009-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded formulation. The formal bioequivalence study with adequate power will be conducted by the manufacturer. In order to get data independently from the manufacturer and to have this information in an earlier phase, this small pilot study is initiated. The initial study showed a declined bioavailability of the granules under fasting conditions. The study has been extended with an arm determining the pharmacokinetics of the granules after food (compared to the oral solution taken with food).Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Radboud UniversityTreatments:
Lopinavir
Ritonavir
Criteria
Inclusion Criteria:- Subject is at least 18 and not older than 55 years of age on the day of the first
dosing.
- Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at
least 3 months prior to the first dosing.
- Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
- Subject is able and willing to sign the Informed Consent Form prior to screening
evaluations.
- Subject is in good age appropriate health condition
- Subject has a normal blood pressure and pulse rate, according to the investigator's
judgment.
- Female subject is either not of childbearing potential, or is of childbearing
potential and practicing one of the following methods of birth control: condoms,
sponge, foams, jellies, diaphragm or copper intrauterine device (IUD); has a
vasectomized partner; or total abstinence from sexual intercourse.
Exclusion Criteria:
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- Positive HIV test.
- Positive hepatitis B or C test.
- Therapy with any drug, including oral contraceptives.
- Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular
disorders, neurological disorders (especially seizures and migraine), gastrointestinal
disorders, renal and hepatic disorders, hormonal disorders (especially diabetes
mellitus), coagulation disorders.
- Relevant history or current condition that might interfere with drug absorption,
distribution, metabolism or excretion.
- History of or current abuse of drugs, alcohol or solvents.
- Inability to understand the nature and extent of the trial and the procedures
required.
- Participation in a drug trial within 60 days prior to the first dose.
- Donation of blood within 60 days prior to the first dose.
- Febrile illness within 3 days before the first dose.
- Pregnancy or breastfeeding.