Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Roxane Laboratories

ClinicalTrials.gov Identifier:

NCT01107353

First received: April 19, 2010

Last updated: May 22, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 19, 2010

Last Updated Date

May 22, 2012

Start Date ^ICMJE

August 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

bioequivalence determined by statistical comparison Cmax [ Time Frame: 33 Days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01107353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

Official Title ^ICMJE

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Imipramine Pamoate Capsules, 75 mg, Under Fasted Conditions

Brief Summary

The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Imipramine Pamoate

75 mg capsule

Other Name: TOFRANIL-PM

Study Arm (s)

Active Comparator: Imipramine Pamoate
Capsule

Intervention: Drug: Imipramine Pamoate
Active Comparator: Tofranil PM
Capsule

Intervention: Drug: Imipramine Pamoate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01107353

Other Study ID Numbers ^ICMJE

IMIP-C75-PVFS-1

Has Data Monitoring Committee

Responsible Party

Roxane Laboratories

Study Sponsor ^ICMJE

Roxane Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Soran Hong, M.D.

Novum Pharmaceutical Research Services

Information Provided By

Roxane Laboratories

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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