NCT00913549

Brief Summary

To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg tablets.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 1989

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1989

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1990

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1990

Completed
19.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

March 28, 2017

Status Verified

June 1, 2009

Enrollment Period

1 month

First QC Date

June 2, 2009

Last Update Submit

March 27, 2017

Conditions

Allergy

Keywords

Antihistamine

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    19 days

Study Arms (2)

1

EXPERIMENTAL

Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)

Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)

2

EXPERIMENTAL

Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)

Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)

Interventions

Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)DRUG
1
Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)DRUG
2

Eligibility Criteria

Age19 Years - 55 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

Hypersensitivity

Interventions

Clemastine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • James C. Kisicki, M.D.

    Harris Laboratories, Incorporated

    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

June 2, 2009

First Posted

June 4, 2009

Study Start

December 1, 1989

Primary Completion

January 1, 1990

Study Completion

January 1, 1990

Last Updated

March 28, 2017

Record last verified: 2009-06