NCT00913419

Brief Summary

To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 depression

Timeline
Completed

Started Nov 1988

Shorter than P25 for phase_1 depression

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

November 1, 1988

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1988

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1988

Completed
20.5 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

Depression

Keywords

Antidepressant

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on AUC and Cmax

    33 days

Study Arms (2)

1

EXPERIMENTAL

Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories

Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories

2

ACTIVE COMPARATOR

Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp \& Dohme

Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme

Interventions

Cyclobenzaprine HCl Tablets 10 mg, Cord LaboratoriesDRUG
1
Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & DohmeDRUG
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

Depression

Interventions

cyclobenzaprine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • A. Orson Brod, M.D.

    PharmaKineticsLaboratories, 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

June 2, 2009

First Posted

June 4, 2009

Study Start

November 1, 1988

Primary Completion

December 1, 1988

Study Completion

December 1, 1988

Last Updated

March 28, 2017

Record last verified: 2009-06