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

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

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 102.94 (90% CI 97.63 to 108.55) NCT01157182 ↗

registry Ratio of the T/R geometric mean x 100 98.40 (90% CI 95.15 to 101.76) NCT01157182 ↗

registry Ratio of the T/R geometric mean x 100 98.73 (90% CI 95.33 to 102.26) NCT01157182 ↗

registry Ratio of the T/R geometric mean x 100 92.51 (90% CI 88.64 to 96.55) NCT01157182 ↗

registry Ratio of the T/R geometric mean x 100 95.66 (90% CI 92.60 to 98.81) NCT01157182 ↗

registry Ratio of the T/R geometric mean x 100 95.71 (90% CI 92.62 to 98.91) NCT01157182 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol	Other / unclassified	1 mg	—
Subject	Norethindrone	Unknown	0.5 mg	—

Indications

No indication recorded.