Supersaturation and precipitation of indinavir in the stomach of healthy human volunteers

Supersaturation and precipitation of indinavir in the stomach of healthy human volunteers - Supersaturation and precipitation of indinavir in the stomach of healthy human volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002830-30-BE

Enrollment

Registered

2014-12-01

Start date

2014-12-24

Completion date

Unknown

Last updated

2020-06-08

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

Conditions

Healthy human volunteers (administration of a Protease inhibitor)

Interventions

Trade Name: CRIXIVAN® 400 mg hard capsules Product Name: Crixivan Product Code: J05AE02 Pharmaceutical Form: Capsule, hard INN or Proposed INN: INDINAVIR SULFATE CAS Number: 150378-17-9 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Healthy volunteers - Age between 18 and 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: The study aims to investigatie principles of gastric supersaturation and precipitation of a weakly basic drug in healthy human volunteers. The influence of nutritional state will also be investigated.;Secondary Objective: Not applicable;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 & Disposition

KU Leuven

jari.rubbens@kuleuven.be+32166377307

Outcome results

None listed

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