drugset / Trial / NCT00835692

Clarithromycin 500 mg Tablets Under Fasting Conditions

NCT00835692 ↗

Phase 1 Completed 60 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-labelOther

Summary

This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects under fasting conditions.

Timeline

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

Outcome

Met primary endpoint

registry analysis (unspecified test); Clarithromycin vs Biaxin®; Test/Ref Ratio of LS Mean x 100 98.4 (90% CI 91.5 to 106) NCT00835692 ↗

registry analysis (unspecified test); Clarithromycin vs Biaxin®; Test/Ref Ratio of LS Means x 100 93.5 (90% CI 89.6 to 97.6) NCT00835692 ↗

registry analysis (unspecified test); Clarithromycin vs Biaxin®; Test/Ref Ratio of LS Means x 100 93.5 (90% CI 89.5 to 97.7) NCT00835692 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 500 mg Oral

Indications

No indication recorded.