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NCT00810108 · ClinicalTrials.gov registry record · Phase 4
Lopinavir/Ritonavir (Kaletra) PK in Children
A Phase 4 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT00810108 is a Phase 4 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 12 participants.
The verdict
NCT00810108, a Phase 4 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-label, crossover study of pediatric subjects already taking lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after taking a dose with tablets swallowed whole.
Interventions
- DRUG lopinavir/ritonavir (Kaletra®) tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-06 |
| Est. Completion | 2009-05 |
| Phase | Phase 4 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00810108
The ClinicalTrials.gov registry entry for NCT00810108 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lopinavir/ritonavir (Kaletra®) tablets is the first listed.
NCT00810108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00810108 about?
NCT00810108 is a clinical study titled "Lopinavir/Ritonavir (Kaletra) PK in Children". The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-label, crossover study of pediatric subjects already taking lopinavir/ritonavir tablets as part of their clinical ...
What is the current status of trial NCT00810108?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2006-06. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00810108?
The interventions under investigation include: lopinavir/ritonavir (Kaletra®) tablets (DRUG).
Who is sponsoring clinical trial NCT00810108?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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