Clinical trial NCT01697436: A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
Official title: A Bioequivalence Study of Ribavirin Oral Solution (RO0209963) Versus the Reference Ribavirin Tablets (Copegus) Following Oral Administration in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This four-period, single-center, open-label, single-dose, randomized, cross-over study will assess the bioequivalence and safety of an oral solution of Copegus (ribavirin) compared to a Copegus tablet in healthy adult volunteers. Volunteers will be randomized to one of four sequences in which they will receive the treatment under fed and under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers
* Able to participate and willing to give informed consent and comply with the study restrictions.
* Negative urine pregnancy test (for women of childbearing potential) documented at screening and within the 24-hour period prior to each dose of test drug
* All male subjects with female partners of childbearing potential must agree to use two reliable forms of contraception, one of which must be a physical barrier method, during the study and for 6 months thereafter
* Female subjects must be postmenopausal or surgically sterile or they must agree to use two reliable forms of contraception one of which must be a physical barrier method, during treatment and for 6 months thereafter
* Body mass index (BMI) \<30 kg/m2

Exclusion Criteria:

* Pregnant or lactating women and male partners of females who are pregnant or lactating
* Positive test for drugs of abuse at screening and within the 24-hour period prior to each dose of test drug.
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average (1 standard unit = 10 grams of alcohol). Alcohol consumption will be prohibited at least 48 hours before screening and from at least 48 hours before Day -1 through the end of the study
* Confirmed systolic blood pressure (SBP) \> 140 or \< 90 mm Hg, and diastolic blood pressure (DBP) \> 90 or \< 50 mm Hg
* Resting pulse rate \> 90 or \< 45 beats per minute
* History or symptoms of any significant disease including (but not limited to) hematological, neurological, psychiatric, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder
* History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma of the skin (e.g., skin basal or squamous cell carcinoma)
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
* Use of any medications (prescription or over-the-counter, vitamin, mineral, herbal, and dietary supplements within 7 days, or less than 5 half-lives (whichever is longer) prior to randomization. Exceptions are acetaminophen (up to 2 g/day), ibuprofen (up to 1 g/day), and hormonal contraceptives.
* Clinically significant abnormalities in laboratory test results
* Participation in an investigational drug study within 60 days or in an investigational device study within 30 days prior to screening
* Donation of blood over 500 mL from 3 months prior to screening until the end of the study; donation of plasma from 7 days prior to screening until the end of the study
* Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study
* Smoker of more than 10 cigarettes per day prior to screening or use of tobacco products equivalent to more than 10 cigarettes per day
* Clinically significant abnormalities in the pre-dose resting electrocardiograms
* Any confirmed significant allergic reactions against RBV or known or potential allergy or hypersensitivity to the non-active ingredients of the study drugs (non-active hay fever is acceptable)
* Individuals receiving ribavirin therapy within 6 months prior to study initiation

Primary outcomes:
measure: Pharmacokinetics: area under the plasma concentration time curve
timeFrame: Periods 1-4: Predose and up to 192 hours post-dose
measure: Pharmacokinetics: maximum plasma concentration
timeFrame: Periods 1-4: Predose and up to 192 hours post-dose
Secondary outcomes:
measure: Safety: incidence of adverse events
timeFrame: Approximately 16 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
state: Kansas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: