Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMBIEN · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Zolpidem | EXPERIMENTAL | Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period |
| Ambien® | ACTIVE_COMPARATOR | Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Zolpidem 10 mg tablets | DRUG | 1 x 10 mg |
| AMBIEN® 10 mg tablets | DRUG | 1 x 10 mg |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less. Exclusion Criteria: * Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointe...
AMBIEN is a small molecule drug developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. It is referenced in clinical development as AMBIEN 10 mg tablets. The listed development stage is Phase 1, and the program covers two completed trials conducted in the United States.
AMBIEN is developed by Teva Pharmaceutical Industries Limited, which is listed under the ticker TEVA. The asset is tracked as AMBIEN 10 mg tablets in the company's clinical program.
AMBIEN is listed at Phase 1 in its development program. Two trials have been completed and none are currently active. The program enrolled a total of 62 participants across both completed studies.
AMBIEN has been studied in two completed Phase 1 trials: NCT00833937, titled Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions, which enrolled 24 participants, and NCT00833521, titled Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions, which enrolled 38 participants. Both were conducted in the United States.
Both AMBIEN Phase 1 trials were randomized and actively controlled, with no double blinding. They enrolled healthy volunteers aged 18 years and older, included all sexes, and were conducted in the United States. Neither trial used biomarker-based patient selection.