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A Single dose, two-way crossover study of the bioequivalence of two formulations of Ribavirin

A Single dose, two-way crossover study of the bioequivalence of two formulations of Ribavirin - BE of Ribavirin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36756
Enrollment
54
Registered
2011-04-11
Start date
2011-05-10
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Hepatitis C

Interventions

Active substance: ribavirin

Sponsors

Schering-Plough
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18-55 years, BMI 18-30 kg/m2 (inclusive) man or postmenopausal women

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/Aids. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months preceding the start of this study.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics Safety

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)