Gastrointestinal behavior of tenofovir DF in healthy volunteers
Phase 1
- Conditions
- healthy volunteers (administration of antiviral drug)Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-005863-25-BE
- Lead Sponsor
- Katholieke Universiteit Leuven - Pharmacotechnology and Biopharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
- healthy volunteers
- age between 18 and 35
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
- pregnancy
- disease
- use of medication
- regular exposure to X-radiation last year
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 behavior and absorption of tenofovir DF.;Secondary Objective: - To compare absorption of tenofovir DF with or without co-medication <br>- To compare fasted versus fed state.;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