Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

Infection Clinical Trial

Official title:

A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 250 mg Clarithromycin Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601315
• Other study ID #: 461-07
• Status: Completed
• Phase: N/A
• First received: September 20, 2007
• Last updated: January 19, 2018
• Start date: April 2003
• Est. completion date: May 2003

Study information

• Verified date: January 2018
• Source: West-Ward Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Clarithromycin

Locations

Country	Name	City	State
United States	MDS Pharma Services	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Roxane Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence		Baseline, Two period, Seven day washout