Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

Roxane Laboratories

Status: Completed

Conditions: Depression

Treatments: Drug: Imipramine Pamoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107353

IMIP-C75-PVFS-1

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

First Imipramine Pamoate, then Tofranil-PM

Active Comparator group

Description:

First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)

Treatment:

Drug: Imipramine Pamoate

First Tofranil PM, then imipramine pamoate

Active Comparator group

Description:

First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)

Treatment:

Drug: Imipramine Pamoate