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

Phase 1 Completed 40 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 fed conditions.

Timeline

Start: 2007-01
Primary completion: 2007-02
Completion: 2007-02

Outcome

Met primary endpoint

registry Ratio of the T/R geometric mean x 100 104.66 (90% CI 94.22 to 116.25) NCT01181726 ↗

registry Ratio of the T/R geometric mean x 100 97.4 (90% CI 93.91 to 101.02) NCT01181726 ↗

registry Ratio of the T/R geometric mean x 100 97.60 (90% CI 94.05 to 101.30) NCT01181726 ↗

registry Ratio of the T/R geometric mean x 100 99.35 (90% CI 92.21 to 107.06) NCT01181726 ↗

registry Ratio of the T/R geometric mean x 100 95.21 (90% CI 91.21 to 99.39) NCT01181726 ↗

registry Ratio of the T/R geometric mean x 100 95.25 (90% CI 91.18 to 99.51) NCT01181726 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estradiol/Norethindrone acetate	Unknown	—	—

Indications

No indication recorded.