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The objective of this study is to establish the relative bioavailability (BA) of two different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation following oral single dose administration in fasting healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranitidine HCL ODT Vanilla-Mint | Experimental |
| |
| Ranitidine HCL ODT RM Vanilla-Mint | Experimental |
| |
| Ranitidine HCL | Active Comparator | Maximum Strength ZANTAC 150® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranitidine hydrochloride ODT | Drug | Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | up to 16 hours after drug administration | |
| Maximum measured concentration of ranitidine in plasma (Cmax) | up to 16 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) | up to 16 hours after drug administration | |
| Time from dosing to the maximum concentration of ranitidine in plasma (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Ranitidine hydrochloride ODT RM | Drug | Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2) |
|
| Ranitidine hydrochloride | Drug |
|
|
| up to 16 hours after drug administration |
| Terminal rate constant in plasma (λz) | up to 16 hours after drug administration |
| Terminal half-life of ranitidine in plasma (t1/2) | up to 16 hours after drug administration |
| Mean residence time of the analyte in the body after po administration (MRTpo) | up to 16 hours after drug administration |
| Apparent clearance of the analyte in the plasma after extravascular administration (CL/F) | up to 16 hours after drug administration |
| Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) | up to 16 hours after drug administration |
| Number of patients with adverse events | up to 38 days |
| Global assessment of tolerability by investigator on a 4-point scale | 24 hours after drug dosing at the end of each treatment period |
| ID | Term |
|---|---|
| D011899 | Ranitidine |
| ID | Term |
|---|---|
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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