NCT01181726

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

A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg Versus Activella® (1 mg Estradiol/0.5 mg Norethindrone Acetate) Tablets in Normal, Healthy, Post-Menopausal Female Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Estradiol/Norethindrone acetate	1 mg/0.5 mg Tablets
DRUG	Activella®	1 mg/0.5 mg Tablets

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2010-08-13
• Last updated: 2010-12-08
• Results posted: 2010-10-07

Locations

1 site across 1 country: Canada