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The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.
The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regime 1 | Experimental | Regime 1 will be orally administered once daily in the morning over 6 consecutive days. |
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| Regime 2 | Active Comparator | Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days |
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| Regime 3 | Active Comparator | Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days. |
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| Regime 4 | Experimental | Regime 4- Day 1- a single dose will be given. Day 2- one placebo capsule; Day 3- a single dose will be given . Day 4 & 5- two placebo capsules on each day; Day 6- a single does will be given. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUR-1025 | Drug | orally, 24 mg, daily for 6 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay. | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sicard, M.D. | Algorithme Pharma Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algorithme Pharma INc. | Mount Royal | Quebec | H3P 3PI | Canada |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| EUR-1025 | Drug | orally, 8 mg, twice daily over 6 consecutive days |
|
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| EUR-1025 | Drug | orally, 8 mg, three times a day over 6 consecutive days |
|
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| EUR-1025 | Drug | orally, 8 mg, 16 mg, 24 mg, daily, for 6 days |
|
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| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |