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The purpose of this study is to compare experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.
Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, comparative oral bioavailability study in healthy, adult, male human subjects under non-fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nizatidine | Drug | Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on Cmax and AUC parameters | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charu Gautam, M.D | Lambda Therapeutic Research Ltd. | Principal Investigator |
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| ID | Term |
|---|---|
| D016567 | Nizatidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Axid | Drug | Axid 300 mg Capsules of Reliant Pharmaceuticals, US |
|
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |