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Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT01107353
Recruitment Status : Completed
First Posted : April 20, 2010
Results First Posted : January 15, 2014
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Intervention Drug: Imipramine Pamoate
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
Hide Arm/Group Description

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

Imipramine Pamoate: 75 mg capsule

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

Imipramine Pamoate: 75 mg capsule

Period Title: Overall Study
Started 20 20
Completed 19 20
Not Completed 1 0
Reason Not Completed
Positive Drug Screen             1             0
Arm/Group Title First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate Total
Hide Arm/Group Description

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

Imipramine Pamoate: 75 mg capsule

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

Imipramine Pamoate: 75 mg capsule

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
Normal healthy volunteers
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
28.41  (7.65) 28.41  (7.65) 28.41  (7.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
6
  30.0%
7
  35.0%
13
  32.5%
Male
14
  70.0%
13
  65.0%
27
  67.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
  95.0%
17
  85.0%
36
  90.0%
White
0
   0.0%
3
  15.0%
3
   7.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.0%
0
   0.0%
1
   2.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Bioequivalence Determined by Statistical Comparison Cmax
Hide Description Blood samples were collected pre-dose and at intervals over 120 hours after each dose
Time Frame 33 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
Hide Arm/Group Description:

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

Imipramine Pamoate: 75 mg capsule

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

Imipramine Pamoate: 75 mg capsule

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
11.5  (7.48) 11.3  (7.03)
Time Frame 33 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
Hide Arm/Group Description

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

Imipramine Pamoate: 75 mg capsule

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

Imipramine Pamoate: 75 mg capsule

All-Cause Mortality
First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Anton (Tony) Amann, PhD., Executive Director, DRAMA
Organization: Roxane Laboratories, Inc.
Phone: 614-272-4785
Responsible Party: West-Ward Pharmaceutical ( Roxane Laboratories )
ClinicalTrials.gov Identifier: NCT01107353     History of Changes
Other Study ID Numbers: IMIP-C75-PVFS-1
First Submitted: April 19, 2010
First Posted: April 20, 2010
Results First Submitted: November 26, 2013
Results First Posted: January 15, 2014
Last Update Posted: February 5, 2018