Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

Next Previous
X
Search
Trial Profile

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 16 Dec 2022

Price :

$35 *

Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Cobicistat/darunavir/emtricitabine/tenofovir alafenamide (Primary) ; Cobicistat; Darunavir; Emtricitabine/tenofovir alafenamide
  • Indications HIV-1 infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Janssen Pharmaceutica; Janssen Sciences Ireland UC

    • Most Recent Events

    • 26 Oct 2022 Results assessing safety and bioequivalence parameters of fixed-dose combination tablet darunavir/cobicistat/emtricitabine/tenofovir alafenamide compared with coadministration of the separate agents in healthy volunteers, presented at the 16th International Congress on Drug Therapy and HIV Infection.
    • 03 Jul 2020 Status changed from recruiting to discontinued.
    • 14 Apr 2020 Planned primary completion date changed from 27 Apr 2020 to 30 May 2020.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top