Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01344369 | Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions | PHASE1 | COMPLETED | 36 | — | — | Aug 1, 2008 | Sep 1, 2008 | May 30, 2011 | 1 | United States |
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 |
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...