Bioequivalency Study of Imipramine Pamoate 75 mg Capsules Under Fasted Conditions

Roxane Laboratories39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression

Interventions

Imipramine PamoateDRUG

75 mg capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Novum Pharmaceutical Research Services

Houston, Texas, United States

Outcomes

Primary Outcomes

Bioequivalence Determined by Statistical Comparison Cmax

Blood samples were collected pre-dose and at intervals over 120 hours after each dose

Time frame: 33 Days

Data from ClinicalTrials.gov

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