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This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects
This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg Tolperisone | Experimental | 50 mg tablets (2 days SD, 2 days TID) |
|
| 100 mg of Tolperisone | Experimental | 100 mg tablets (2 days SD, 2 days TID) |
|
| 200 mg Tolperisone | Experimental | 200 mg tablets (2 days SD, 2 days TID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolperisone | Drug | tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration of tolperisone | taken over 4 days per dose |
| Tmax | Time of maximum plasma concentration of tolperisone | taken over 4 days per dose |
| AUC | Area under the curve of tolperisone plasma concentrations | taken over 4 days per dose |
| T1/2 | Half life of tolperisone | taken over 4 days per dose |
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Inclusion Criteria:
Exclusion Criteria:
- pregnant or breastfeeding
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials Early Phase Services, LLC | San Antonio | Texas | 78217 | United States |
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| ID | Term |
|---|---|
| D014049 | Tolperisone |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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sequence randomized
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |