NCT00960479

Brief Summary

The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under fasting conditions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2001

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
Last Updated

March 28, 2017

Status Verified

August 1, 2009

Enrollment Period

1 month

First QC Date

August 13, 2009

Last Update Submit

March 27, 2017

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    30 days

Study Arms (2)

1

EXPERIMENTAL

Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)

Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)

2

ACTIVE COMPARATOR

Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)

Drug: Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)

Interventions

Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)DRUG
1
Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)DRUG
2

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Piyush Patel, M.D.

    Allied Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 17, 2009

Study Start

January 1, 2001

Primary Completion

February 1, 2001

Study Completion

February 1, 2001

Last Updated

March 28, 2017

Record last verified: 2009-08