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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00946790
Other study ID # 005-14-10551
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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