Bioequivalence study of CRUshed Sofosbuvir/velpAtasvir compareD to the wholE tablet (CRUSADE-1)/Hep-NED004

Phase 4

Completed

Conditions: Hepatitis C
liver disease caused by the hepatitis C virus
10047438

Registration Number: NL-OMON45504

Lead Sponsor: Afdeling Apotheek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

1.Patients with sofosbuvir/velpatasvir treatment for the treatment of chronic hepatitis C genotype 1 through 6.
2. Patient is at least 18 at the day of screening.
3. Patient is able and willing to sign the Informed Consent Form.
4. Patient is able and willing to follow protocol requirements.

Exclusion Criteria

1. Pregnant female (as confirmed by an hCG test performed 4 weeks before Day 84) or breast-feeding female.
2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion except for conditions related to HCV.
3. Inability to understand the nature and extent of the study and the procedures required.
4. Clinically relevant low hemoglobin concentration at screening judged by the patient*s own physician.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim of this study is to assess the bioequivalence of SOF/VEL<br /><br>administered as a crushed (test) tablet compared to a whole (reference) tablet<br /><br>in patients treated with SOF/VEL.<br /><br><br /><br>Geometric Mean Ratios and the 90% CI interval of the pharmacokinetic parameters<br /><br>(AUC0-tau, Cmax,ss and Ctrough) and median of t* and tmax,ss of sofosbuvir,<br /><br>GS-331007 and velpatasvir of a crushed tablet (intervention) compared to a<br /><br>whole tablet (reference).<br /><br><br /><br>AUC0-24 and Cmax,ss GMR with a 90% CI falling entirely within the range of 0.8<br /><br>to 1.25 are considered bioequivalent.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of crushed SOF/VEL tablets in patients.<br /><br>Adverse events after administration of (crushed) SOF/VEL will be described and<br /><br>compared (including clinically relevant laboratory abnormalities).</p><br>