drugset / Trial / NCT01157182

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions

NCT01157182

Phase 1 Completed 36 enrolled Teva Pharmaceuticals USA
RandomizedCrossoverOpen-label

Summary

The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fasting conditions.

Timeline

Start
2007-02
Primary completion
2007-04
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified 1 mg
Subject Norethindrone Unknown 0.5 mg

Indications

No indication recorded.