Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01107353
First received: April 19, 2010
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Depression
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Roxane Laboratories
ClinicalTrials.gov 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:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014