Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Imipramine Pamoate Capsules, 75 mg, Under Fasted Conditions
1 other identifier
interventional
39
1 country
1
Brief Summary
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Aug 2008
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedResults Posted
Study results publicly available
January 15, 2014
CompletedFebruary 5, 2018
January 1, 2018
1 month
April 19, 2010
November 26, 2013
January 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Bioequivalence Determined by Statistical Comparison Cmax
Blood samples were collected pre-dose and at intervals over 120 hours after each dose
33 Days
Study Arms (2)
First Imipramine Pamoate, then Tofranil-PM
ACTIVE COMPARATORFirst 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)
First Tofranil PM, then imipramine pamoate
ACTIVE COMPARATORFirst 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
Interventions
75 mg capsule
Eligibility Criteria
You may qualify if:
- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novum Pharmaceutical Research Services
Houston, Texas, 77042-4712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anton (Tony) Amann, PhD., Executive Director, DRAMA
- Organization
- Roxane Laboratories, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Soran Hong, M.D.
Novum Pharmaceutical Research Services
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 20, 2010
Study Start
August 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
February 5, 2018
Results First Posted
January 15, 2014
Record last verified: 2018-01