Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

Roxane Laboratories40 enrolled

Overview

The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infection

Interventions

ClarithromycinDRUG

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 clarithromycin or any other macrolide antibiotic.

Locations (1)

MDS Pharma Services

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two period, Seven day washout

Data from ClinicalTrials.gov

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