Behaviour of ritonavir in the gastrointestinal tract of healthy volunteers

Phase 1

• Conditions: Healthy human volunteers; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2016-002700-78-BE
• Lead Sponsor: KU Leuven - Drug Delivery and Disposition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-21
• Study Completion: 2018-08-27
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

healthy volunteers
age: 18 - 35 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- disease
- acute/chronic GI condition
- use of medication
- pregnancy
- frequent exposure to X-rays during the past year
- HIV / HBV / HCV infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the gastrointestinal behaviour of a weakly basic drug (ritonavir) in healthy volunteers and its implications for systemic drug exposure;Secondary Objective: To investigate food effects reported for both ritonavir-containing dosage forms in literature.;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable