Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations
Phase 1
Completed
- Conditions
- Bioequivalence Study in Healthy Subjects
- Interventions
- 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: 5 mg Flupentixol coated tablet (reference treatment)Drug: 1 mg Flupentixol coated tablet (reference treatment)
- Registration Number
- NCT02660840
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 0.5 mg Test, then 0.5 mg reference 0.5 mg Flupentixol film-coated tablet (test treatment) 14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference) 0.5 mg Test, then 0.5 mg reference 0.5 mg Flupentixol coated tablet (reference treatment) 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 0.5 mg Flupentixol film-coated tablet (test treatment) 14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test) 0.5 mg reference, then 0.5 mg Test 0.5 mg Flupentixol coated tablet (reference treatment) 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 1 mg Flupentixol film-coated tablet (test treatment) 14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference) 5 mg Test, then 5 mg reference 5 mg Flupentixol coated tablet (reference treatment) 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 5 mg Flupentixol film-coated tablet (test treatment) 14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test) 5 mg reference, then 5 mg Test 5 mg Flupentixol coated tablet (reference treatment) 14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test) 1 mg Test, then 1 mg reference 1 mg Flupentixol coated tablet (reference treatment) 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 1 mg Flupentixol film-coated tablet (test treatment) 14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test) 1 mg reference, then 1 mg Test 1 mg Flupentixol coated tablet (reference treatment) 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 5 mg Flupentixol film-coated tablet (test treatment) 14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference)
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
RU801
🇷🇺Moscow, Russian Federation