To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets

NCT ID: NCT00913809

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

1987-12-31

Study Completion Date

1987-12-31

Brief Summary

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To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets.

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

Desipramine HCL 100 mg Tablets Cord Laboratories

Group Type EXPERIMENTAL

Desipramine HCL 100 mg Tablets Cord Laboratories

Intervention Type DRUG

2

Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc

Group Type ACTIVE_COMPARATOR

Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc

Intervention Type DRUG

Interventions

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Desipramine HCL 100 mg Tablets Cord Laboratories

Intervention Type DRUG

Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc

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

50 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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Jules Kann, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Biodecision Laboratories

Other Identifiers

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870609-D

Identifier Type: -

Identifier Source: org_study_id

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