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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01161927 | Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Jul 1, 2004 | Sep 1, 2004 | Jul 14, 2010 | - | — |
| NCT01161940 | Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Jul 1, 2004 | Sep 1, 2004 | Jul 14, 2010 | - | — |
| Arm | Type | Description |
|---|---|---|
| Nizatidine | EXPERIMENTAL | Nizatidine Capsules 300 mg of Dr.Reddy'sLaboratories Limited |
| Axid | ACTIVE_COMPARATOR | Axid 300 mg Capsules of Reliant Pharmaceuticals, US |
| Name | Type | Description |
|---|---|---|
| Nizatidine | DRUG | Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited |
| Axid | DRUG | Axid 300 mg Capsules of Reliant Pharmaceuticals, US |
Inclusion Criteria: * Healthy males between 18 and 55 years of age (inclusive) living in and around Ahmedabad city of western part of India. * Having a Body Mass Index (BMI) ≥ 18.0 kg/m2 (calculated as weight in kg/ height in m2). * Have no significant diseases or clinically significant abnormal fi...