NCT00946790

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 1993

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1993

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1993

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1993

Completed
15.7 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

March 28, 2017

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

July 24, 2009

Last Update Submit

March 27, 2017

Conditions

ImmunosuppressionRheumatism

Keywords

Immunosuppressant and Antirheumatic

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    171 days

Study Arms (2)

1

EXPERIMENTAL

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

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

2

ACTIVE COMPARATOR

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

Drug: Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)

Interventions

Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)DRUG
1
Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)DRUG
2

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

HydroxychloroquineTrifyba

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gerald Gantt, M.D.

    PharmaKinetics Laboratories Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

July 1, 1993

Primary Completion

December 1, 1993

Study Completion

December 1, 1993

Last Updated

March 28, 2017

Record last verified: 2009-07