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Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

NCT ID: NCT01107353

Last Updated: 2018-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-09-30

Brief Summary

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The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting 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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First Imipramine Pamoate, then Tofranil-PM

First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)

Group Type ACTIVE_COMPARATOR

Imipramine Pamoate

Intervention Type DRUG

75 mg capsule

First Tofranil PM, then imipramine pamoate

First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)

Group Type ACTIVE_COMPARATOR

Imipramine Pamoate

Intervention Type DRUG

75 mg capsule

Interventions

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Imipramine Pamoate

75 mg capsule

Intervention Type DRUG

Other Intervention Names

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TOFRANIL-PM

Eligibility Criteria

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Inclusion Criteria

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to imipramine pamoate or any comparable or similar product.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roxane Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Soran Hong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Locations

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Novum Pharmaceutical Research Services

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IMIP-C75-PVFS-1

Identifier Type: -

Identifier Source: org_study_id

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