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Bioequivalence Study to Compare Two Formulations of Deanxit®

NCT03472651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-29

No results posted yet for this study

Summary

The purpose of this study is to establish bioequivalence of flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered single dose in fasted and fed condition

Conditions

  • Healthy

Interventions

DRUG

test treatment: flupentixol/melitracen

0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose

DRUG

reference treatment: flupentixol/melitracen

0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2018-06-28
Completion
2018-06-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03472651 on ClinicalTrials.gov