Recent Updates
Recently added Catalysts

Ribavirin

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

Ribavirin · 2 trials · 1 indication

Phase 1 2
NCT00835146Ribavirin 200 mg Tablets Under Fasting ConditionsHealthy
COMPLETED28 Analytics
NCT00835536Ribavirin 200 mg Tablets Under Non-Fasting ConditionsHealthy
COMPLETED27 Analytics
PHASE1COMPLETED
Ribavirin 200 mg Tablets Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Ribavirin 200 mg Tablets Under Non-Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 72 hour period.

Bioequivalence based on Cmax.

AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)
Blood samples collected over a 72 hour period.

Bioequivalence based on AUC0-72.

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Ribavirin 200 mg tabletsDRUG1 x 200 mg, single-dose fasting
COPEGUS™DRUG1 x 200 mg, single-dose fasting
COPEGUS™ 200 mg TabletsDRUG1 x 200 mg, single-dose non-fasting
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * All subjects selected for this study will be non-smokers, at least 18 years of age, and a female whi is physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile). Subjects will have a BMI (body mass index) of 30 or less. * Each subject s...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Ribavirin

What is Ribavirin used for?

Ribavirin is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating the drug under fasting and non-fasting conditions. The drug is being developed by Teva Pharmaceutical Industries Limited.

Who makes Ribavirin?

Ribavirin is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development, with two completed trials in healthy volunteers.

What phase is Ribavirin in?

Ribavirin is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy female volunteers aged 18 years and older. The trials were conducted in the United States and evaluated the drug under fasting and non-fasting conditions.

What clinical trials is Ribavirin in?

Ribavirin has two completed Phase 1 clinical trials. NCT00835146 evaluated Ribavirin 200 mg tablets under fasting conditions with 28 participants, and NCT00835536 evaluated the same dose under non-fasting conditions with 27 participants. Both trials enrolled healthy female volunteers in the United States.

Is Ribavirin FDA approved?

Ribavirin is an investigational drug currently in Phase 1 clinical development. It has not been approved by the FDA, as it is still being studied in clinical trials. The two completed trials were conducted in healthy volunteers to evaluate the drug's effects under different conditions.