Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02660840

Enrollment

84

Registered

2016-01-21

Start date

2016-01-31

Completion date

Unknown

Last updated

2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence Study in Healthy Subjects

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

Interventions

DRUG0.5 mg Flupentixol film-coated tablet (test treatment)

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

DRUG1 mg Flupentixol film-coated tablet (test treatment)

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

DRUG5 mg Flupentixol film-coated tablet (test treatment)

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

DRUG0.5 mg Flupentixol coated tablet (reference treatment)

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

DRUG1 mg Flupentixol coated tablet (reference treatment)

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

DRUG5 mg Flupentixol coated tablet (reference treatment)

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

Sponsors

H. Lundbeck A/S

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026