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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 drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed, and the studies conducted to date have enrolled healthy adult male volunteers rather than patients with a named disease.
Nizatidine targets HRH2, the histamine H2 receptor, and acts as an antagonist at that receptor. By binding HRH2 as an antagonist, the drug blocks histamine-mediated signaling at this receptor. This target class and mechanism define how the molecule is characterized in pharmacological terms.
Nizatidine is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical studies registered for this asset, including the two completed Phase 1 bioequivalence trials of nizatidine capsules 300 mg conducted under fasting and non-fasting conditions.
Nizatidine is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The program has not been approved, and it remains an investigational asset rather than a marketed product based on the development stage recorded for it.
Nizatidine has been evaluated in two completed Phase 1 bioequivalence trials: NCT01161940, conducted under fasting conditions, and NCT01161927, conducted under non-fasting conditions. Both studied nizatidine capsules 300 mg in healthy male volunteers aged 18 years and older, with 26 participants enrolled in each trial.
Both Nizatidine trials were randomized, active-controlled Phase 1 bioequivalence studies of nizatidine capsules 300 mg. Each enrolled 26 healthy male volunteers aged 18 years and older, one under fasting conditions and one under non-fasting conditions. Together the two completed trials enrolled 52 participants, and neither was double-blind.