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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00834717 | Granisetron 1 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 40 | — | — | Sep 1, 2005 | Sep 1, 2005 | Aug 19, 2024 | 1 | Canada |
| NCT00834522 | Granisetron 1 mg Tablets, Non-fasting | PHASE1 | COMPLETED | 80 | — | — | Jul 1, 2005 | Jul 1, 2005 | Aug 19, 2024 | 1 | Canada |
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...