Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Bioequivalence Study in Healthy Subjects

Treatments: Drug: 1 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: 0.5 mg Flupentixol film-coated tablet (test treatment); Drug: 5 mg Flupentixol coated tablet (reference treatment); Drug: 5 mg Flupentixol film-coated tablet (test treatment)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02660840

15969A

Details and patient eligibility

About

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

Full 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

Enrollment: 84 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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84 participants in 6 patient groups

0.5 mg Test, then 0.5 mg reference

Experimental group

Description:

14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference)

Treatment:

Drug: 0.5 mg Flupentixol film-coated tablet (test treatment)

Drug: 0.5 mg Flupentixol coated tablet (reference treatment)

0.5 mg reference, then 0.5 mg Test

Experimental group

Description:

14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test)

Treatment:

Drug: 0.5 mg Flupentixol film-coated tablet (test treatment)

Drug: 0.5 mg Flupentixol coated tablet (reference treatment)

1 mg Test, then 1 mg reference

Experimental group

Description:

14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference)

Treatment:

Drug: 1 mg Flupentixol coated tablet (reference treatment)

Drug: 1 mg Flupentixol film-coated tablet (test treatment)

1 mg reference, then 1 mg Test

Experimental group

Description:

14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test)

Treatment:

Drug: 1 mg Flupentixol coated tablet (reference treatment)

Drug: 1 mg Flupentixol film-coated tablet (test treatment)

5 mg Test, then 5 mg reference

Experimental group

Description:

14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference)

Treatment:

Drug: 5 mg Flupentixol coated tablet (reference treatment)

Drug: 5 mg Flupentixol film-coated tablet (test treatment)

5 mg reference, then 5 mg Test

Experimental group

Description:

14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test)

Treatment:

Drug: 5 mg Flupentixol coated tablet (reference treatment)

Drug: 5 mg Flupentixol film-coated tablet (test treatment)