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Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01107353
Collaborator
(none)
39
Enrollment
1
Location
2
Arms
1
Duration (Months)
38.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Imipramine Pamoate
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Imipramine Pamoate Capsules, 75 mg, Under Fasted Conditions
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: First Imipramine Pamoate, then Tofranil-PM

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

Drug: Imipramine Pamoate
75 mg capsule
Other Names:
  • TOFRANIL-PM

    		•
    Active Comparator: First Tofranil PM, then imipramine pamoate

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

    Drug: Imipramine Pamoate
    75 mg capsule
    Other Names:
  • TOFRANIL-PM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bioequivalence Determined by Statistical Comparison Cmax [33 Days]

      Blood samples were collected pre-dose and at intervals over 120 hours after each dose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novum Pharmaceutical Research Services Houston Texas United States 77042-4712

    Sponsors and Collaborators

    • Roxane Laboratories

    Investigators

    • Principal Investigator: Soran Hong, M.D., Novum Pharmaceutical Research Services

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roxane Laboratories
    ClinicalTrials.gov Identifier:
    NCT01107353
    Other Study ID Numbers:
    • IMIP-C75-PVFS-1
    First Posted:
    Apr 20, 2010
    Last Update Posted:
    Feb 5, 2018
    Last Verified:
    Jan 1, 2018
    Additional relevant MeSH terms:
    Depression
    Imipramine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
    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

    Baseline Characteristics

    Arm/Group Title First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate Total
    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 Participants 20 20 40
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    28.41
    (7.65)
    28.41
    (7.65)
    28.41
    (7.65)
    Sex: Female, Male (Count of Participants)
    Female
    6
    30%
    7
    35%
    13
    32.5%
    Male
    14
    70%
    13
    65%
    27
    67.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    19
    95%
    17
    85%
    36
    90%
    White
    0
    0%
    3
    15%
    3
    7.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    5%
    0
    0%
    1
    2.5%
    Region of Enrollment (participants) [Number]
    United States
    20
    100%
    20
    100%
    40
    100%

    Outcome Measures

    1. Primary Outcome
    Title Bioequivalence Determined by Statistical Comparison Cmax
    Description Blood samples were collected pre-dose and at intervals over 120 hours after each dose
    Time Frame 33 Days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
    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
    Measure Participants 19 19
    Mean (Standard Deviation) [ng/mL]
    11.5
    (7.48)
    11.3
    (7.03)

    Adverse Events

    Time Frame 33 days
    Adverse Event Reporting Description
    Arm/Group Title First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
    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 (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/20 (0%)
    Other (Not Including Serious) Adverse Events
    First Imipramine Pamoate, Then Tofranil-PM First Tofranil PM, Then Imipramine Pamoate
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/20 (0%) 0/20 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Anton (Tony) Amann, PhD., Executive Director, DRAMA
    Organization Roxane Laboratories, Inc.
    Phone 614-272-4785
    Email tony.amann@boehringer-ingelheim.com
    Responsible Party:
    Roxane Laboratories
    ClinicalTrials.gov Identifier:
    NCT01107353
    Other Study ID Numbers:
    • IMIP-C75-PVFS-1
    First Posted:
    Apr 20, 2010
    Last Update Posted:
    Feb 5, 2018
    Last Verified:
    Jan 1, 2018