Ketamine Clinical Trials
A Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study of a Test Tablet Formulation of Ravidasvir with the Reference Tablet Formulation of Ravidasvir in Healthy Adult Volunteers Under Fasting Conditions
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Organisation Name: Drug for Neglected Diseases initiative
Overal Status: Completed
Start Date: 14/02/2020
Brief Summary: Ravidasvir, is being developed for the treatment of Hepatitis C, a liver disease caused by a virus (HCV). Ravidasvir is a NS5A inhibitor, which exhibits potent inhibition of HCV replication in HCV replicon assays. In an ongoing phase II/III study, it was hypothesized that sofosbuvir plus ravidasvir constitutes a pan-genotypic, potent and safe regimen which can be used in decentralized public health settings under the supervision of appropriately trained health care professionals. Such a combination will not require intensive pre-treatment evaluation or monitoring and can thus be scaled up together with active identification and linkage to care of HCV infected persons. 301 patients were included in the study and preliminary data are very promising. During the course of development, a new batch of ravidasvir tablets has been prepared by the proposed commercial manufacturer (Doppel Farmaceutici, Italy) with an Active Pharmaceutical Ingredient (API) manufactured by Pharco B International (Egypt). Tablets manufactured from the Pharco B international API are intended to be used in subsequent clinical trials and be registered as the commercial product. Countries
We are doing this assay to assess if ravidasvir 200 mg tablets supplied by Doppel Farmaceutici from CAD Middle East Pharmaceutical Industries LLC (Saudi Arabia) API and tablets from Doppel Farmaceutici from the Pharco B international API are bioequivalent.
The study will be done at a single site: Clinical Research Ward at Ampang Hospital.
- Kuala Lampur
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