NCT03602300

A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

In a phase 1, open-label, crossover study to evaluate the relative bioavailability of a tablet formulation of ravidasvir (test) versus the capsule formulation of ravidasvir (reference) in 24 healthy adult volunteers (PPI-668-104 study), relatively high intra-subject coefficients of variation were observed for both Cmax and AUC0-t. A two-sequence, four-period replicate design will be used to allow the possibility to scale the acceptance range for Cmax if the observed intra-subject coefficient of variation for the reference formulation is greater than 30%

Detailed description

During the course of development, a new batch of ravidasvir tablets has been prepared by the proposed commercial manufacturer (Doppel Farmaceutici, Italy). Tablets manufactured by Doppel Farmaceutici are intended to be used in subsequent clinical trials and be registered as the commercial product. The purpose of this Phase 1, Open-Label, Four-Period, Two-Sequence, Two-Treatment, Single Dose, Randomized, Crossover Bioequivalence Study is to assess if ravidasvir 200 mg tablets supplied by European Egyptian Pharmaceutical Industries (EEPI) and tablets from Doppel Farmaceutici are bioequivalent. Primary objectives: To compare the rate and extent of absorption for ravidasvir (RDV) when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions. Secondary objectives To evaluate the safety and tolerability of single oral doses of RDV in healthy volunteers.

Conditions

• Bioequivalence Study

Interventions

Type	Name	Description
DRUG	Ravidasvir test formulation produced by Doppel	To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions.
DRUG	Ravidasvir reference formulation produced by EEPI	To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product ("test") produced by Doppel Farmaceutici with the clinical trial product ("reference") manufactured by EEPI in healthy volunteers, under fasted conditions.

Timeline

• Start date: 2018-06-05
• Primary completion: 2018-08-17
• Completion: 2018-08-17
• First posted: 2018-07-26
• Last updated: 2020-01-31

Locations

1 site across 1 country: Malaysia