Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Granisetron · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Granisetron | EXPERIMENTAL | Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period |
| Kytril® | ACTIVE_COMPARATOR | Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Granisetron hydrochloride 1 mg tablets | DRUG | 2 x 1 mg, single dose fasting |
| Kytril® 1 mg tablets | DRUG | 2 x 1 mg, single dose fasting |
Inclusion Criteria: * Healthy, non-smoking, male and female subjects, 18 years of age or older. * BMI ≥ 19 and ≤ 30. * No significant diseases or clinically significant findings in a physical examination. * No clinically significant abnormal laboratory values. * No clinically significant findings i...
Granisetron is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied in bioavailability trials to assess how it is absorbed and processed by the body.
Granisetron is being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with trials focused on evaluating the drug's bioavailability under fasting and non-fasting conditions. The drug is not yet approved for any medical condition.
Granisetron is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's bioavailability in healthy volunteers.
Granisetron is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trials are designed to assess the drug's bioavailability in healthy volunteers under different dietary conditions.
Granisetron has two completed Phase 1 clinical trials: NCT00834522, a non-fasting bioavailability study with 80 participants, and NCT00834717, a fasting bioavailability study with 40 participants. Both trials enrolled healthy volunteers aged 18 years and older in Canada.
Granisetron is the generic name for the drug also known as Kytril. However, the clinical trials listed here are for a specific formulation of granisetron 1 mg tablets being developed by Teva Pharmaceutical Industries Limited, and they are focused on bioavailability testing in healthy volunteers.