drugset / Trial / NCT00840411

Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions

NCT00840411 ↗

Phase 1 Completed 66 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test population of 66 adult subjects under fasting conditions.

Timeline

Start
2002-09
Primary completion
2002-10
Completion
2002-10

Outcome

Met primary endpoint

registry Test/Ref Ratio of LS Means x 100 100.0 (90% CI 93.3 to 107.1) NCT00840411 ↗

registry Ratio of Least Squares Means 86.5 (90% CI 80.1 to 93.4) NCT00840411 ↗

registry Ratio of Least Squares Means 87.2 (90% CI 81.0 to 93.8) NCT00840411 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 500 mg Oral

Indications

No indication recorded.