Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

NCT ID: NCT02660840

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31

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

Conditions

Bioequivalence Study in Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

0.5 mg Test, then 0.5 mg reference

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

Group Type: EXPERIMENTAL

0.5 mg Flupentixol film-coated tablet (test treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

0.5 mg Flupentixol coated tablet (reference treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

0.5 mg reference, then 0.5 mg Test

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

Group Type: EXPERIMENTAL

0.5 mg Flupentixol film-coated tablet (test treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

0.5 mg Flupentixol coated tablet (reference treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

1 mg Test, then 1 mg reference

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

Group Type: EXPERIMENTAL

1 mg Flupentixol film-coated tablet (test treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

1 mg Flupentixol coated tablet (reference treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

1 mg reference, then 1 mg Test

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

Group Type: EXPERIMENTAL

1 mg Flupentixol film-coated tablet (test treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

1 mg Flupentixol coated tablet (reference treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

5 mg Test, then 5 mg reference

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

Group Type: EXPERIMENTAL

5 mg Flupentixol film-coated tablet (test treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

5 mg Flupentixol coated tablet (reference treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

5 mg reference, then 5 mg Test

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

Group Type: EXPERIMENTAL

5 mg Flupentixol film-coated tablet (test treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

5 mg Flupentixol coated tablet (reference treatment)

Intervention Type: DRUG

single oral dose, fasted state, day 1 in period 1 or 2

Interventions

0.5 mg Flupentixol film-coated tablet (test treatment)

single oral dose, fasted state, day 1 in period 1 or 2

Intervention Type: DRUG

1 mg Flupentixol film-coated tablet (test treatment)

single oral dose, fasted state, day 1 in period 1 or 2

Intervention Type: DRUG

5 mg Flupentixol film-coated tablet (test treatment)

single oral dose, fasted state, day 1 in period 1 or 2

Intervention Type: DRUG

0.5 mg Flupentixol coated tablet (reference treatment)

single oral dose, fasted state, day 1 in period 1 or 2

Intervention Type: DRUG

1 mg Flupentixol coated tablet (reference treatment)

single oral dose, fasted state, day 1 in period 1 or 2

Intervention Type: DRUG

5 mg Flupentixol coated tablet (reference treatment)

single oral dose, fasted state, day 1 in period 1 or 2

Intervention Type: DRUG

Other Intervention Names

Fluanxol®; Fluanxol®; Fluanxol®

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

RU801

Moscow, , Russia

Countries

Russia

Other Identifiers

15969A

Identifier Type: -

Identifier Source: org_study_id