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 being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating its effects under fasting and non-fasting conditions. The drug is being developed by Teva Pharmaceutical Industries Limited.
AMBIEN is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical trials, with two completed studies in healthy volunteers.
AMBIEN is in Phase 1 clinical development. It has completed two Phase 1 trials, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
AMBIEN has two completed Phase 1 clinical trials. NCT00833521 studied Zolpidem Tartrate 10 mg tablets under fasting conditions with 38 participants, and NCT00833937 studied the same tablets under non-fasting conditions with 24 participants. Both trials were conducted in the United States.
AMBIEN is the brand name for the drug, and the clinical trials for AMBIEN use Zolpidem Tartrate 10 mg tablets. The trials are titled 'Zolpidem Tartrate 10 mg Tablets' under fasting and non-fasting conditions, indicating that AMBIEN contains the active ingredient zolpidem tartrate.