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Ribavirin 200

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Novartis AG|Last Updated: Mar 28, 2017

Target and mechanism

ModalitySmall molecule

Also known as Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Ribavirin 200 · 1 trial · 1 indication

Phase 1 1
NCT00959933Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Non-Fasting ConditionsChronic Hepatitis C
COMPLETED24 Analytics
PHASE1COMPLETED
Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Non-Fasting Conditions
Chronic Hepatitis C
NCT0095993324
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Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRibavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)
2ACTIVE_COMPARATORRebetol 200 Capsules (Schering Corporation, U.S.A.)

Interventions

NameTypeDescription
Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.)DRUG -
Rebetol 200 Capsules (Schering Corporation, U.S.A.)DRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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