To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories; Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913419

9038A

Details and patient eligibility

About

To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.

Enrollment: 30 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1

Experimental group

Description:

Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories

Treatment:

Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories

2

Active Comparator group

Description:

Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp \& Dohme

Treatment:

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