Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMARYL · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUCinf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Glimepiride | EXPERIMENTAL | Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period |
| Amaryl® | ACTIVE_COMPARATOR | Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Glimepiride 4 mg Tablets | DRUG | 1 x 4 mg, single-dose non-fasting |
| AMARYL® 4 mg Tablets | DRUG | 1 x 4 mg, single-dose non-fasting |
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. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but i...
AMARYL is a small molecule drug being developed by Teva Pharmaceutical Industries Limited. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and it is not yet approved for any medical condition.
AMARYL is being studied for use in healthy individuals as part of clinical trials. It is currently in Phase 1 development, meaning it is being tested for safety and tolerability in healthy volunteers. It is not yet approved for any specific medical indication.
AMARYL is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug in healthy volunteers.
AMARYL is in Phase 1 clinical development. It has completed two Phase 1 trials, both of which were conducted in healthy volunteers in the United States. The drug is still in the early stages of clinical testing and is not yet approved.
AMARYL has been studied in two completed Phase 1 clinical trials: NCT00834340, which evaluated glimepiride 4 mg tablets under fasting conditions, and NCT00835172, which evaluated the same tablets under non-fasting conditions. Both trials enrolled 32 healthy volunteers each.
AMARYL is being studied as glimepiride 4 mg tablets in clinical trials. The trials listed under the drug name AMARYL use glimepiride as the active ingredient, indicating that AMARYL is a brand name for glimepiride.