Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Interventional, Open-label, Randomised, Crossover, Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations - Film Coated Tablet (Test Treatment) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) and Coated Tablet (Fluanxol®) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) in Healthy Volunteers

Conditions
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Bioequivalence Study in Healthy Subjects

Intervention / Treatment
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* Drug: 0.5 mg Flupentixol film-coated tablet (test treatment)
* Drug: 1 mg Flupentixol film-coated tablet (test treatment)
* Drug: 5 mg Flupentixol film-coated tablet (test treatment)
* Drug: 0.5 mg Flupentixol coated tablet (reference treatment)
* Drug: 1 mg Flupentixol coated tablet (reference treatment)
* Drug: 5 mg Flupentixol coated tablet (reference treatment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index (BMI) of ≥18.5 and ≤30 kg/m2 The subject is, in the opinion of the investigator, generally healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. Exclusion Criteria: The subject is pregnant or breastfeeding. The subject has taken any investigational medicinal products 3 months prior to the first dose The subject has tested positive at the Screening Visit or at the Baseline Visit for drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, benzodiazepines, and cannabinoids). Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 mg Test, then 0.5 mg reference<br>14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference) | Drug: 0.5 mg Flupentixol film-coated tablet (test treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>Drug: 0.5 mg Flupentixol coated tablet (reference treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>* Other names: Fluanxol®;|
| Experimental: 0.5 mg reference, then 0.5 mg Test<br>14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test) | Drug: 0.5 mg Flupentixol film-coated tablet (test treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>Drug: 0.5 mg Flupentixol coated tablet (reference treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>* Other names: Fluanxol®;|
| Experimental: 1 mg Test, then 1 mg reference<br>14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference) | Drug: 1 mg Flupentixol film-coated tablet (test treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>Drug: 1 mg Flupentixol coated tablet (reference treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>* Other names: Fluanxol®;|
| Experimental: 1 mg reference, then 1 mg Test<br>14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test) | Drug: 1 mg Flupentixol film-coated tablet (test treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>Drug: 1 mg Flupentixol coated tablet (reference treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>* Other names: Fluanxol®;|
| Experimental: 5 mg Test, then 5 mg reference<br>14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference) | Drug: 5 mg Flupentixol film-coated tablet (test treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>Drug: 5 mg Flupentixol coated tablet (reference treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>* Other names: Fluanxol®;|
| Experimental: 5 mg reference, then 5 mg Test<br>14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test) | Drug: 5 mg Flupentixol film-coated tablet (test treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>Drug: 5 mg Flupentixol coated tablet (reference treatment)<br>* single oral dose, fasted state, day 1 in period 1 or 2<br>* Other names: Fluanxol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |