- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00946790
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
March 27, 2017 updated by: Sandoz
Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
|
|
Active Comparator: 2
Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on AUC and Cmax
Time Frame: 171 days
|
171 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gerald Gantt, M.D., PharmaKinetics Laboratories Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1993
Primary Completion (Actual)
December 1, 1993
Study Completion (Actual)
December 1, 1993
Study Registration Dates
First Submitted
July 24, 2009
First Submitted That Met QC Criteria
July 24, 2009
First Posted (Estimate)
July 27, 2009
Study Record Updates
Last Update Posted (Actual)
March 28, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005-14-10551
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Immunosuppression
-
Linda CendalesRecruitingImmunosuppressionUnited States
-
Erasmus Medical CenterCompleted
-
Hospices Civils de LyonWithdrawn
-
Weill Medical College of Cornell UniversityTerminatedImmunosuppressionUnited States
-
University of PittsburghNovartis PharmaceuticalsCompletedImmunosuppressionUnited States
-
ShuGuang HospitalGuangdong Provincial People's HospitalCompleted
-
Medical University of South CarolinaAstellas Pharma IncCompletedImmunosuppressionUnited States
-
Medical University of South CarolinaCompletedImmunosuppressionUnited States
-
Edward GeisslerChiesi Pharmaceuticals GmbHRecruiting
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingImmunosuppressionUnited States
Clinical Trials on Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
-
SandozCompleted
-
SandozCompletedRheumatoid Arthritis | Psoriatic Arthritis
-
SandozCompleted
-
Cambridge University Hospitals NHS Foundation TrustUniversity of CambridgeWithdrawn
-
First Affiliated Hospital of Harbin Medical UniversityUnknown
-
Taoyuan General HospitalNational Health Research Institutes, Taiwan; Centers for Disease Control, Taiwan and other collaboratorsCompletedCoronavirus InfectionTaiwan
-
SandozCompleted
-
Tan Tock Seng HospitalNetherlands: Ministry of Health, Welfare and Sports; Duke-NUS Graduate Medical... and other collaboratorsWithdrawnCoronavirus Infection | Hydroxychloroquine Adverse Reaction
-
SandozCompletedHypertension | Angina