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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01511705 | Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition | PHASE1 | COMPLETED | 26 | — | — | Oct 1, 2006 | Oct 1, 2006 | Jan 19, 2012 | 1 | India |
| NCT01511718 | Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition | PHASE1 | COMPLETED | 26 | — | — | Oct 1, 2006 | Oct 1, 2006 | Jan 19, 2012 | 1 | India |
| Arm | Type | Description |
|---|---|---|
| Ondansetron Hydrochloride Tablets 8 mg | EXPERIMENTAL | Ondansetron Hydrochloride Tablets 8 mg of Dr. Reddy's Laboratories Limited |
| Zofran Tablets 8 mg | ACTIVE_COMPARATOR | Zofran Tablets 8 mg of GlaxoSmithKline |
| Name | Type | Description |
|---|---|---|
| Ondansetron Hydrochloride | DRUG | Ondansetron Hydrochloride Tablets 8 mg |
Inclusion Criteria: * Subjects who provide written informed consent. * Subjects who were healthy adults within 18 and 45 years of age (both inclusive). * Body mass index of ≥ 18 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg. * Subjects who had normal health as determined by medical his...