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Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

This study has been completed.
Information provided by (Responsible Party):
Roxane Laboratories Identifier:
First received: April 19, 2010
Last updated: November 26, 2013
Last verified: November 2013
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions

Condition Intervention
Drug: Imipramine Pamoate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence Determined by Statistical Comparison Cmax [ Time Frame: 33 Days ] [ Designated as safety issue: No ]
    Blood samples were collected pre-dose and at intervals over 120 hours after each dose

Enrollment: 39
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01107353

United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042-4712
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Soran Hong, M.D. Novum Pharmaceutical Research Services
  More Information

Responsible Party: Roxane Laboratories Identifier: NCT01107353     History of Changes
Other Study ID Numbers: IMIP-C75-PVFS-1 
Study First Received: April 19, 2010
Results First Received: November 26, 2013
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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 processed this record on October 21, 2016