To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals); Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913783

920256

Details and patient eligibility

About

To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fasted conditions.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 45 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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36 participants in 2 patient groups

1

Experimental group

Description:

Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)

Treatment:

Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)

2

Active Comparator group

Description:

Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Treatment:

Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)