Trials Sponsors Conditions Drugs Pricing

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

Bioequivalence Determined by Statistical Comparison Cmax
Blood samples were collected pre-dose and at intervals over 120 hours after each dose
33 Days

Study Arms (2)

First Imipramine Pamoate, then Tofranil-PM

ACTIVE COMPARATOR

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

Drug: Imipramine Pamoate

First Tofranil PM, then imipramine pamoate

ACTIVE COMPARATOR

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

Drug: Imipramine Pamoate

Interventions

Imipramine PamoateDrug

75 mg capsule

Also known as: TOFRANIL-PM

First Imipramine Pamoate, then Tofranil-PMFirst Tofranil PM, then imipramine pamoate

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Roxane Laboratories
Industrylead

Study Sites (1)

Novum Pharmaceutical Research Services

Houston, Texas, 77042-4712, United States

MeSH Terms

Conditions

Depression

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Anton (Tony) Amann, PhD., Executive Director, DRAMA
Organization: Roxane Laboratories, Inc.

Study Officials

Soran Hong, M.D.
Novum Pharmaceutical Research Services
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

39 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 20, 2010

Study Start

August 2008

Date type not reported

This date has not been verified as actual or estimated.

Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

First Imipramine Pamoate, then Tofranil-PM

First Tofranil PM, then imipramine pamoate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

First Imipramine Pamoate, then Tofranil-PM

First Tofranil PM, then imipramine pamoate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations