Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 combination oral contraceptive being studied for bioequivalence in healthy female volunteers. It is a small molecule product under development by Teva Pharmaceutical Industries Limited. Clinical trials have assessed the 0.4 mg/35 mcg chewable tablet formulation under fasting and non-fasted conditions.
Teva Pharmaceutical Industries Limited (NYSE: TEVA) is developing Norethindrone/Ethinyl Estradiol. The company has conducted Phase 1 clinical trials for this combination oral contraceptive product in the United States.
Norethindrone/Ethinyl Estradiol is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, each enrolling 36 healthy female participants aged 18 years and older. The drug is investigational and not yet approved.
Norethindrone/Ethinyl Estradiol has been studied in two completed Phase 1 trials: NCT01340625, a fasting-condition bioequivalence study, and NCT01344369, a non-fasted-condition study. Both were active-controlled, randomized trials conducted in the United States with 36 healthy female participants each.
Norethindrone/Ethinyl Estradiol is being developed as a 0.4 mg/35 mcg chewable tablet. The clinical trials specifically evaluated the chewable formulation under fasting and non-fasted conditions to assess bioequivalence in healthy female volunteers.