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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions; Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions; Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913952

940155

Details and patient eligibility

About

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

Enrollment: 18 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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18 participants in 3 patient groups

1

Experimental group

Description:

Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions.

Treatment:

Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions

2

Experimental group

Description:

Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.

Treatment:

Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions

3

Active Comparator group

Description:

Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.

Treatment:

Drug: Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions