Pharmacokinetic Study of Two Generic co-Formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF) (SURF)
Information provided by (Responsible Party)
First received: April 23, 2008
Last updated: February 24, 2009
Last Verified: February 2009
History of Changes
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).
Drug : Lopinavir/ritonavir
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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).|
Further study details as provided by Radboud University:
Primary Outcome Measures
- Plasma concentrations of lopinavir and ritonavir. [ Time Frame: 0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 24 and 32 hours post ingestion (11 samples) on Days 1, 8 and 15. ]
- safety: adverse events [ Time Frame: entire study ]
|Study Start Date:||September 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Lopinavir/ritonavir 200/50mg; 2 tablets; single dose
Other Name: Kaletra
Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose
Other Name: Lopimune granules
Lopinavir/ritonavir 100/25mg; 4 tablets; single dose
Other Name: Lopimune tablets
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.
To evaluate the safety of single-dose administration of the two generic co-formulations of lopinavir/ritonavir and compare this to the branded product.
|Ages Eligible for Study:||18 Years to 55 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665951
Locations Show More
|Radboud University Medical Centre|
|Nijmegen, Gelderland, Netherlands|
Sponsors and CollaboratorsRadboud University
|Principal Investigator:||David M Burger||Radboud University|
|Responsible Party:||Dr. D.M. Burger, hospital pharmacist, Radboud University Nijmegen Medical Centre|
|ClinicalTrials.gov Identifier:||NCT00665951 History of Changes|
|Other Study ID Numbers:||UMCN-AKF 07.04|
|Study First Received:||April 23, 2008|
|Last Updated:||February 24, 2009|
Keywords provided by Radboud University:pediatric
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on May 29, 2020
This information is provided by ClinicalTrials.gov.