Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

Bioequivalence Study in Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660840
• Other study ID #: 15969A
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2016
• Last updated: July 25, 2016
• Start date: January 2016

Study information

• Verified date: July 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioequivalence Study in Healthy Subjects

Intervention

Drug:
• 0.5 mg Flupentixol film-coated tablet (test treatment)
single oral dose, fasted state, day 1 in period 1 or 2
• 1 mg Flupentixol film-coated tablet (test treatment)
single oral dose, fasted state, day 1 in period 1 or 2
• 5 mg Flupentixol film-coated tablet (test treatment)
single oral dose, fasted state, day 1 in period 1 or 2
• 0.5 mg Flupentixol coated tablet (reference treatment)
single oral dose, fasted state, day 1 in period 1 or 2
• 1 mg Flupentixol coated tablet (reference treatment)
single oral dose, fasted state, day 1 in period 1 or 2
• 5 mg Flupentixol coated tablet (reference treatment)
single oral dose, fasted state, day 1 in period 1 or 2

Locations

Country	Name	City	State
Russian Federation	RU801	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area under the plasma concentration-time curve		from 0 to 72 hours post-dose	No
Primary	The maximum observed concentration (Cmax)		from 0 to 72 hours post-dose	No