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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 )

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
Depression Drug: Imipramine Pamoate Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : August 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


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 Name: 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 Name: TOFRANIL-PM




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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107353


Locations
United States, Texas
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

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01107353     History of Changes
Other Study ID Numbers: IMIP-C75-PVFS-1
First Posted: April 20, 2010    Key Record Dates
Results First Posted: January 15, 2014
Last Update Posted: February 5, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs