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OpenTrials
Completed

NCT Number: NCT00602498

Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions

The objective of this study was the bioequivalence of a potential generic 500 mg clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin tablet, Biaxin® following a single 500 mg dose, administered with food.

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Key information

Conditions

Infection Infections

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MDS Pharma Services

Phoenix, Arizona, 85044-5318, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clarithromycin

Drug

Primary outcomes

  1. Bioequivalence

    Time frame: Baseline, Two period, Seven day washout

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 500 mg Clarithromycin Tablets Under Fed Conditions

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Jan 28, 2008
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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