Gastrointestinal behavior of tenofovir DF in healthy volunteers

Gastrointestinal behavior of tenofovir DF in healthy volunteers - Gastrointestinal behavior of tenofovir DF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005863-25-BE

Enrollment

Registered

2012-01-19

Start date

2012-04-26

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

healthy volunteers (administration of antiviral drug)

Interventions

Trade Name: Viread Pharmaceutical Form: Tablet INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATE CAS Number: 202138-50-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - pregnancy - disease - use of medication - regular exposure to X-radiation last year

Design outcomes

Primary

Measure	Time frame
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 - To compare fasted versus fed state.;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 ContactPharmacotechnology and Biopharmacy

Katholieke Universiteit Leuven

joachim.brouwers@pharm.kuleuven.be3216330300

Outcome results

None listed

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