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Also known as Zeosa®
Norethindrone/Ethinyl Estradiol · 2 trials · 2 indications
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva) |
| Reference Listed Drug | ACTIVE_COMPARATOR | FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) |
| Name | Type | Description |
|---|---|---|
| Norethindrone/Ethinyl Estradiol | DRUG | 0.4 mg/0.035 mg Chewable Tablets |
| FEMCON® Fe | DRUG | 0.4 mg/0.035 mg Chewable Tablets |
| Ovcon® 35 Fe | DRUG | 0.4 mg/35 mcg Chewable Tablets |
Inclusion Criteria: * Females, 18-45 years of age inclusive with Body Mass Index within 18-30 kg/m2 inclusive, as described in Novum Standard Operating Procedures. Female subjects must either abstain from sexual intercourse or use a reliable non-hormonal method of contraception (e.g. condom with sp...
Norethindrone/ethinyl estradiol is a small molecule combination product developed by Teva Pharmaceutical Industries Limited. It combines a progestin and an estrogen and is being studied in Phase 1 clinical development. The specific therapeutic indication for this Teva asset is not publicly disclosed.
Norethindrone/ethinyl estradiol targets the progesterone receptor, known as PGR, where it acts as an agonist. The progesterone receptor is a nuclear hormone receptor that mediates progestin signaling. This receptor-level activity underlies the pharmacologic profile of the combination.
Teva Pharmaceutical Industries Limited is developing norethindrone/ethinyl estradiol. Teva trades on the New York Stock Exchange under the ticker TEVA. The company is the sponsor of the clinical studies registered for this chewable tablet formulation.
Norethindrone/ethinyl estradiol is in Phase 1 clinical development. It is an investigational product and is not approved based on the development information available. Both registered trials for this asset have completed, and no trials are currently active.
Two completed Phase 1 trials have studied norethindrone/ethinyl estradiol 0.4 mg/35 mcg chewable tablets. NCT01344369 evaluated the tablets under non-fasted conditions, and NCT01340625 evaluated them under fasting conditions for bioequivalence. Each trial enrolled 36 healthy female volunteers in the United States, for 72 participants total.
Both Phase 1 trials of norethindrone/ethinyl estradiol were randomized, active-controlled studies in healthy female volunteers aged 18 years and older. The trials were not double-blind. One assessed the chewable tablets under fasting conditions and the other under non-fasted conditions, with 36 participants each.