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PK Linearity and Steady State PK of CHF 6532 in Healthy Subjects

NCT03942666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-07-22

No results posted yet for this study

Summary

The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after single oral administrations of four doses of a tablet formulation and to evaluate the pharmacokinetic (PK) at steady state following the repeated open label b.i.d. administration at one dose.

Conditions

Interventions

DRUG

Treatment A

tablet of CHF 6532

DRUG

Treatment B

tablet of CHF 6532

DRUG

Treatment C

tablet of CHF 6532

DRUG

Treatment D

tablet of CHF 6532

DRUG

Treatment E

Placebo tablet of CHF 6532

DRUG

Treatment F

tablet of CHF 6532

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2019-11-22
Completion
2019-11-22

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT03942666 on ClinicalTrials.gov