To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Immunosuppression Clinical Trial

Official title:

Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946790
• Other study ID #: 005-14-10551
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2009
• Last updated: March 27, 2017
• Start date: July 1993
• Est. completion date: December 1993

Study information

• Verified date: July 2009
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 1993
• Est. primary completion date: December 1993
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immunosuppression
• Rheumatic Diseases
• Rheumatism

Intervention

Drug:
• Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)

• Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on AUC and Cmax		171 days