drugset / Trial / NCT00847405

Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions

NCT00847405 ↗

Phase 1 Completed 28 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-label

Summary

The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fasting conditions.

Timeline

Start
2003-03
Primary completion
2003-03
Completion
2003-03

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 103.64 (90% CI 95.93 to 111.97) NCT00847405 ↗

registry Ratio of the T/R geometric mean x 100 102.81 (90% CI 97.95 to 107.91) NCT00847405 ↗

registry Ratio of the T/R geometric mean x 100 103.25 (90% CI 98.35 to 108.41) NCT00847405 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sumatriptan Unknown 100 mg —

Indications

No indication recorded.