Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00960479

First received: August 13, 2009

Last updated: August 14, 2009

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 13, 2009

Last Updated Date

August 14, 2009

Start Date ^ICMJE

January 2001

Primary Completion Date

February 2001 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence based on AUC and Cmax [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00960479 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions

Official Title ^ICMJE

A Relative Bioavailability Study of Ribavirin (Geneva Pharmaceutical Technology Corporation, N.J., U.S.A.) 200 Capsules and Rebetol (Schering Corporation, N.J., U.S.A.) 200 mg Capsules in Females Under Fasting Conditions.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis C

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)

Intervention: Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)
Active Comparator: 2
Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2001

Primary Completion Date

February 2001 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00960479

Other Study ID Numbers ^ICMJE

P1BH00001

Has Data Monitoring Committee

Not Provided

Responsible Party

Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.

Study Sponsor ^ICMJE

Sandoz Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Piyush Patel, M.D.

Allied Clinical Research

Information Provided By

Sandoz

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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