Ignite Creation Date:
2024-05-06 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03602300
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2018-06-21
Brief Title:
A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir Study
Sponsor:
Drugs for Neglected Diseases
Organization:
Drugs for Neglected Diseases
Study Overview
Official Title:
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
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None