Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

Not Applicable

Completed

• Conditions: Depression
• Interventions: Drug: Imipramine Pamoate

• Registration Number: NCT01107353
• Lead Sponsor: Roxane Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Results First Submitted: 2013-11-26
• Results First Submitted QC: 2013-11-26
• Results First Posted: 2014-01-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Tofranil PM, then imipramine pamoate	Imipramine Pamoate	First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
First Imipramine Pamoate, then Tofranil-PM	Imipramine Pamoate	First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)

Primary Outcome Measures

Name	Time	Method
Bioequivalence Determined by Statistical Comparison Cmax	33 Days	Blood samples were collected pre-dose and at intervals over 120 hours after each dose

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Houston, Texas, United States