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

NCT ID: NCT00913783

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-11-30

Study Completion Date

1992-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)

Group Type EXPERIMENTAL

Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)

Intervention Type DRUG

2

Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Group Type ACTIVE_COMPARATOR

Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Intervention Type DRUG

Interventions

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Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)

Intervention Type DRUG

Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Sandoz Inc.

Principal Investigators

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Richard Lalonde, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Phoenix International Life Science Inc.

Other Identifiers

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920256

Identifier Type: -

Identifier Source: org_study_id

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