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Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)

NCT00665951 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-11-12

No results posted yet for this study

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).

Conditions

  • HIV Infections

Interventions

DRUG

Lopinavir/ritonavir

Lopinavir/ritonavir 200/50mg; 2 tablets; single dose

DRUG

Lopinavir/ritonavir

Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose

DRUG

Lopinavir/ritonavir

Lopinavir/ritonavir 100/25mg; 4 tablets; single dose

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • David M Burger · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665951 on ClinicalTrials.gov