Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions
Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Imipramine Pamoate (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Soran Hong, M.D., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
Summary
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg
Capsules under fasting conditions
Clinical Details
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Imipramine Pamoate Capsules, 75 mg, Under Fasted Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence Determined by Statistical Comparison Cmax
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Novum Pharmaceutical Research Services, Houston, Texas 77042-4712, United States
Additional Information
Starting date: August 2008
Last updated: November 26, 2013
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