Behaviour of ritonavir in the gastrointestinal tract of healthy volunteers

Supersaturation and precipitation of ritonavir in the gastrointestinal tract of healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002700-78-BE

Enrollment

Registered

2016-09-21

Start date

2016-10-28

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy human volunteers

Interventions

Trade Name: NORVIR siroop (80 mg / mL) Product Name: Norvir Pharmaceutical Form: Syrup INN or Proposed INN: RITONAVIR CAS Number: 155213-67-5 Concentration unit: mg/ml milligram(s)/millilitre Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactDrug Delivery and Disposition

KU Leuven

jens.vandenabeele@kuleuven.be+3216379105

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026