## Protocol Section
### Identification Module
**NCT ID:** NCT00960479

**Brief Title:** Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions

**Official Title:** 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.

#### Organization Study ID Info
**ID:** P1BH00001
#### Organization
**Class:** INDUSTRY
**Full Name:** Sandoz
### Status Module
#### Completion Date
**Date:** 2001-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-03-28

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2001-02

**Type:** ACTUAL

#### Start Date
**Date:** 2001-01

**Status Verified Date:** 2009-08

#### Study First Post Date
**Date:** 2009-08-17
**Type:** ESTIMATED
**Study First Submit Date:** 2009-08-13
**Study First Submit QC Date:** 2009-08-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sandoz

#### Responsible Party

**Old Name Title:** Eric Mittleberg, Ph.D, VP of Product Development

**Old Organization:** Sandoz Inc.

### Description Module

**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.

### Conditions Module

**Conditions:**

- Chronic Hepatitis C

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

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

**Label:** 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

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

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 2

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

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Bioequivalence based on AUC and Cmax

**Time Frame:** 30 days

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Allied Clinical Research

**Name:** Piyush Patel, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006505

- Term: Hepatitis

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000018178

- Term: Flaviviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000006521

- Term: Hepatitis, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: LOW

- As Found: Unknown

- ID: M9591

- Name: Hepatitis

- Relevance: LOW

- As Found: Unknown

- ID: M9607

- Name: Hepatitis, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M21613

- Name: Hepatitis C, Chronic

- Relevance: HIGH

- As Found: Chronic Hepatitis C

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006526

- Term: Hepatitis C

- ID: D000019698

- Term: Hepatitis C, Chronic

### Intervention Browse Module - Ancestors

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M15083

- Name: Ribavirin

- Relevance: HIGH

- As Found: Bevacizumab

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000012254

- Term: Ribavirin

### Misc Info Module

- Version Holder: 2024-05-24
