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To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses
All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours post-dose) for each dosing period. First and second dosing will be separated by a washout period of at least 21 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg Test, then 0.5 mg reference | Experimental | 14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference) |
|
| 0.5 mg reference, then 0.5 mg Test | Experimental | 14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test) |
|
| 1 mg Test, then 1 mg reference | Experimental | 14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference) |
|
| 1 mg reference, then 1 mg Test | Experimental | 14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test) |
|
| 5 mg Test, then 5 mg reference |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg Flupentixol film-coated tablet (test treatment) | Drug | single oral dose, fasted state, day 1 in period 1 or 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve | from 0 to 72 hours post-dose | |
| The maximum observed concentration (Cmax) | from 0 to 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RU801 | Moscow | Russia |
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| Experimental |
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference) |
|
| 5 mg reference, then 5 mg Test | Experimental | 14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test) |
|
| 1 mg Flupentixol film-coated tablet (test treatment) | Drug | single oral dose, fasted state, day 1 in period 1 or 2 |
|
| 5 mg Flupentixol film-coated tablet (test treatment) | Drug | single oral dose, fasted state, day 1 in period 1 or 2 |
|
| 0.5 mg Flupentixol coated tablet (reference treatment) | Drug | single oral dose, fasted state, day 1 in period 1 or 2 |
|
|
| 1 mg Flupentixol coated tablet (reference treatment) | Drug | single oral dose, fasted state, day 1 in period 1 or 2 |
|
|
| 5 mg Flupentixol coated tablet (reference treatment) | Drug | single oral dose, fasted state, day 1 in period 1 or 2 |
|
|
| ID | Term |
|---|---|
| D005475 | Flupenthixol |
| ID | Term |
|---|---|
| D013892 | Thioxanthenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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