Pharmacokinetic Study of Two Generic co-Formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)
Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Lopinavir/ritonavir (Drug); Lopinavir/ritonavir (Drug); Lopinavir/ritonavir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Radboud University Official(s) and/or principal investigator(s): David M Burger, Principal Investigator, Affiliation: Radboud University
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).
Clinical Details
Official title: The Pharmacokinetics of Two Generic co-Formulations of Lopinavir/Ritonavir for HIV Infected Children: a Pilot Study of Lopimune vs. the Branded Product (SURF Study).
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma concentrations of lopinavir and ritonavir.
Secondary outcome: safety: adverse events
Detailed description:
Cipla has developed two co-formulated forms of lopinavir/ritonavir for second-line
antiretroviral therapy for children: Lopimune granules and Lopimune tablets. They contain
100mg lopinavir and 25mg ritonavir.
Primary objective of this study:
To determine the pharmacokinetic profile of lopinavir and ritonavir in two different
co-formulations (Lopimune granules and Lopimune tablets) after single-dose in HIV-negative,
healthy adult subjects, and to compare this to the branded product.
Secondary objective:
To evaluate the safety of single-dose administration of the two generic co-formulations of
lopinavir/ritonavir and compare this to the branded product.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands
Additional Information
Starting date: September 2008
Last updated: February 24, 2009
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