A Phase I randomized, open-label, single dose, 3-period crossover trial in healthy subjects to evaluate the relative oral bioavailability of the 25 mg and 100 mg tablets of TMC125.

A Phase I randomized, open-label, single dose, 3-period crossover trial in healthy subjects to evaluate the relative oral bioavailability of the 25 mg and 100 mg tablets of TMC125. - Trial to evaluate the relative bioavailability of TMC125.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30258

Enrollment

Registered

2006-10-26

Start date

2006-10-30

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

AIDS HIV

Interventions

One dose per period.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants may not have smoked for the last 3 months preceding the start of the trial. Participants have to be healthy on base of physical examination, medical history, ECG, laboratory tests and blood pressure and pulse rate.

Exclusion criteria

Exclusion criteria: Participants may not have (had) relevant skin diseases or use medicines. The participants may not have participated in more than 1 study with TMC125, TMC120 and/or TMC278 (previously R278474) or having developed rash while participating in a trial with any of these compounds. Females may not be fertile anymore.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic analysis, blood and urine examination, side-effects (adverse events), laboratory results, blood pressure, pulse rate, ECG, alcohol breath test.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)