A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01697436
First received: September 28, 2012
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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 trea tment under fed and under fasted conditions.


Condition Intervention Phase
Healthy Volunteer
Drug: ribavirin [Copegus]
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Bioequivalence Study of Ribavirin Oral Solution (RO0209963) Versus the Reference Ribavirin Tablets (Copegus) Following Oral Administration in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: area under the plasma concentration time curve [ Time Frame: Periods 1-4: Predose and up to 192 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: maximum plasma concentration [ Time Frame: Periods 1-4: Predose and up to 192 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: incidence of adverse events [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crossover Period 1 Drug: ribavirin [Copegus]
tablet under fed condition
Experimental: Crossover Period 2 Drug: ribavirin [Copegus]
tablet under fasted condition
Experimental: Crossover Period 3 Drug: ribavirin [Copegus]
oral solution under fed condition
Experimental: Crossover Period 4 Drug: ribavirin [Copegus]
oral solution under fasted condition

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697436

Locations
United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01697436     History of Changes
Other Study ID Numbers: BP28307
Study First Received: September 28, 2012
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ribavirin
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 01, 2014