A phase I, open-label, randomized crossover trial in 24 healthy subjects to investigate the effect of steady-state esomeprazole on the pharmacokinetics of a single dose of telaprevir.

A phase I, open-label, randomized crossover trial in 24 healthy subjects to investigate the effect of steady-state esomeprazole on the pharmacokinetics of a single dose of telaprevir. - Open-label, crossover of a single dose of telaprevir.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31863

Enrollment

Registered

2008-02-26

Start date

2008-03-01

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

contagius jaundice viral leverinflammation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male or female, aged between 18-55 years of age (extremes included). Females, postmenopausal for at least 2 years, or posthysterectomy or post-tubal ligation. Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening. A body mass index of 18 to 30 kg/m^2 (extremes included)

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at screening

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics For more specifications see the protocol.	—

Secondary

Measure	Time frame
To investigate the safety and tolerability. For more specifications see the protocol.	—

Countries

Netherlands

Outcome results