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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01170169 | Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions | PHASE1 | COMPLETED | 44 | — | — | Jan 1, 2006 | Mar 1, 2006 | Jul 27, 2010 | - | — |
| Arm | Type | Description |
|---|---|---|
| Omeprazole | EXPERIMENTAL | Omeprazole Delayed Release Capsules of Dr. Reddy's laboratories limited |
| Prilosec | ACTIVE_COMPARATOR | Prilosec® 40 mg of Merck \& Co.Inc. |
| Name | Type | Description |
|---|---|---|
| Omeprazole | DRUG | Omeprazole Delayed Release Capsules 40 mg |
| Prilosec | DRUG | Prilosec® 40 mg of Merck \& Co.Inc. |
Inclusion Criteria: * Subjects who provided written informed consent. * Subjects who were healthy within 18-45 years of age, weighing at least 50 kg. * Body mass index of ≥ 18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg. * Subjects with normal health as determined by medical history ...