Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

Completed · Not applicable

Conditions studied: Infection

In brief

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.

Key facts

Study ID

NCT00601315

Run by

Roxane Laboratories

People needed

40

Starts

2003-04-01

Expected to finish

2003-05-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if…

• 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.

Where it is running

• MDS Pharma Services — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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