A Phase I, Open-label, Randomized, 2-panel, 2-way Crossover Pivotal Bioequivalence Trial Between the Commercially Available 400-mg Tablet Formulation (F030) and the 800-mg Tablet Formulation of Darunavir (G002), in the Presence of Low-dose Ritonavir Under Fasted and Fed Conditions
Phase of Trial: Phase I
Latest Information Update: 01 Sep 2014
At a glance
- Drugs Darunavir (Primary) ; Ritonavir
- Indications HIV infections
- Focus Pharmacokinetics; Registrational
- Sponsors Janssen R&D Ireland
- 01 Jan 2013 Primary endpoint 'Drug-concentration' has been met.
- 30 Jun 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
- 01 Apr 2011 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.