NCT01340625

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions

A Relative Bioavailability Study of 0.4 mg/35 Mcg Norethindrone and Ethinyl Estradiol Chewable Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 \* 0.4 mg/35 mcg chewable tablets) in healthy female adult volunteers administered under fasting conditions.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Norethindrone/Ethinyl Estradiol	0.4 mg/35 mcg Chewable Tablets
DRUG	Ovcon® 35 Fe	0.4 mg/35 mcg Chewable Tablets

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2011-04-22
• Last updated: 2011-05-25
• Results posted: 2011-05-25

Locations

1 site across 1 country: United States