Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nizatidine · 2 trials · 1 indication
| 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...
Nizatidine is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development by Dr. Reddy's Laboratories Ltd. The ongoing research focuses on bioequivalence of the 300 mg capsule formulation under fasting and non-fasting conditions.
Nizatidine is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting Phase 1 clinical trials to evaluate the bioequivalence of its 300 mg nizatidine capsules.
Nizatidine is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, each enrolling 26 healthy male volunteers aged 18 years and older. The drug is investigational and has not been approved for marketing.
Nizatidine has two completed Phase 1 clinical trials. NCT01161927 is a bioequivalence study of nizatidine capsules 300 mg under non-fasting conditions, and NCT01161940 is the same study under fasting conditions. Both trials enrolled healthy male volunteers and were active-controlled.
Nizatidine is being studied as a generic version of the drug. The clinical trials conducted by Dr. Reddy's Laboratories Ltd are bioequivalence studies comparing their 300 mg nizatidine capsules to a reference product under fasting and non-fasting conditions in healthy volunteers.