Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

NCT02660840 | Completed Phase 1

• 1 other identifier: 15969A
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Bioequivalence Study in Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

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)

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

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); Drug: 0.5 mg Flupentixol coated tablet (reference treatment)

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)

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

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)

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

5 mg Test, then 5 mg reference

EXPERIMENTAL

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); Drug: 5 mg Flupentixol coated tablet (reference treatment)

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)

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

Interventions

0.5 mg Flupentixol film-coated tablet (test treatment) DRUG

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

0.5 mg Test, then 0.5 mg reference; 0.5 mg reference, then 0.5 mg Test

1 mg Flupentixol film-coated tablet (test treatment) DRUG

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

1 mg Test, then 1 mg reference; 1 mg reference, then 1 mg Test

5 mg Flupentixol film-coated tablet (test treatment) DRUG

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

5 mg Test, then 5 mg reference; 5 mg reference, then 5 mg Test

0.5 mg Flupentixol coated tablet (reference treatment) DRUG

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

Also known as: Fluanxol®

0.5 mg Test, then 0.5 mg reference; 0.5 mg reference, then 0.5 mg Test

1 mg Flupentixol coated tablet (reference treatment) DRUG

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

Also known as: Fluanxol®

1 mg Test, then 1 mg reference; 1 mg reference, then 1 mg Test

5 mg Flupentixol coated tablet (reference treatment) DRUG

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

Also known as: Fluanxol®

5 mg Test, then 5 mg reference; 5 mg reference, then 5 mg Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

RU801

Moscow, Russia

Location

MeSH Terms

Interventions

Flupenthixol

Intervention Hierarchy (Ancestors)

Thioxanthenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 21, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

RU (1)