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

The drug to be given, Ribavirin is registered for the treatment of chronic
hepatitis C virus (HCV) as part of a combination therapy with two other
medications (peginterferon alfa-2b or interferon alfa-2b) registered for the
treatment of hepatitis C and part of the standard-of-care treatment. Hepatitis
C is an infectious disease affecting the liver and is spread by blood-to-blood
contact.
Ribavirin is approved as capsules containing 200 mg of ribavirin or as a
solution for pediatric use containing 40 mg/mL ribavirin. In this study we want
to confirm that both formulations are essentially the same in their effects,
efficacy and safety.

To assess the bioequivalence of two marketed formulations of ribavirin
(ribavirin solution and capsules).

Design:
An open-label, randomized, two-way crossover bioequivalence study in fifty four
healthy male and/or healthy female (postmenopausal/sterilized) subjects
receiving a single oral dose of ribavirin as oral solution in one period and a
single oral dose of ribavirin as capsules in the other period; a washout of at
least five weeks between dosing

Screening and follow-up:
Clinical laboratory, vital signs (including oral temperature), physical
examination, weight, 12-lead ECG; at eligibility screening: medical history,
height, elbow breadth measurement, drug screen, E2 and FSH (PM females only),
HBsAg, anti HCV, anti-HIV 1/2 and pregnancy test (surgically sterile females
only); follow-up at discharge from clinic in Period 2; physical examination,
drug screen, clinical laboratory and vital signs (including oral temperature)
to be repeated upon admission Period 1; pregnancy test (surgically sterile
females only).

Observation period:
2 periods, each period in clinic from -17 h up to 72 h after drug administration

Blood sampling:
Por pharmacokinetics of ribavirin in plasma: pre-dose and at 0.25, 0.5, 0.75,
1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 14, 24, 36, 48, and 72 hours post dose
Day 1.
for genotyping: pre-dose (first period only)

Safety assessments:
Adverse events: throughout the study; weight: pre-dose; vital signs (including
oral temperature): pre-dose and once on Day 4;

Bioanalysis:
Analysis of plasma ribavirin samples using a validated method by Sponsor

Active substance: ribavirin

Procedures: pain, light bleeding, heamatoma and possibly an infection.