NCT02447393

Brief Summary

This is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1 month

First QC Date

June 23, 2011

Last Update Submit

August 1, 2017

Conditions

Dermatitis

Outcome Measures

Primary Outcomes (2)

  • AUC0-48 of levocetirizine

    Area Under the time-concentlation curve

    predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose

  • Cmax of levocetirizine

    maximum concentration

    predose,0.25,0.5,1,1.5,2,3,4,6,9,12,16,24,36, 48 hours post-dose

Secondary Outcomes (4)

  • Number of Adverse events

    predose,1,24 48 hours post-dose

  • Changes in clinical laboratory tests

    predose,24,48 hours post-dose

  • Changes in vital signs

    predose,1,24,48 hours post-dose

  • Changes in 12-lead ECG.

    predose,1,24,48 hours post-dose

Study Arms (3)

levocetirizine

OTHER

Study Drug

Drug: levocetirizine

cetirizine

OTHER

Study Drug

Drug: cetirizine

placebo

OTHER

Study Drug

Drug: placebo

Interventions

levocetirizineDRUG

levocetirizine

levocetirizine
cetirizineDRUG

cetiridine

cetirizine
placeboDRUG

placebo

placebo

Eligibility Criteria

Age20 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese healthy male subjects aged between 20 and 64 years of age inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests.
  • Body weight ≥ 50 kg and BMI within the range 18.50-25.00 kg/m2 inclusive.
  • Non-smokers (at least 6 months).
  • Clinical laboratory tests data obtained at screening meet the following:
  • AST(GOT), ALT(GPT), total-bilirubin, BUN, creatinine, uric acid,: below the upper normal range
  • Normal 12-lead EGC finding at screening; QTc interval \<450msec
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

  • The subject has an allergy for any drug or idiosyncrasy.
  • The subject has a history of allergic rhinitis.
  • The subject has a history or presence of clinically significant gastrointestinal, hepatic or renal disease or other condition known to interfere with absorption, distribution, metabolism or elimination of drugs.
  • The subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
  • The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.
  • The subject has a history or current conditions of drug abuse or alcoholism.
  • History of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink = 150mL of wine or 360mL of beer or 45mL of 80 proof distilled spirits).
  • The subject is positive for urine drug screening.
  • The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
  • The subject has donated a unit of blood "\>400mL" within the previous 4 months or "\>200mL" within the previous 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Kagoshima, 890-0081, Japan

Location

Related Publications (1)

  • Hiroko Ino, Shigeru Nohda, Shuji Miki, Kastutoshi Hara, Toshiyasu Hirama. Comparison of levocetirizine pharmacokinetics, following a single dose of levocetirizine alone or as cetirizine in Japanese healthy male volunteers . [Jpn J Clin Pharmacol Therapeut]. 2010;41(6):309.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Dermatitis

Interventions

levocetirizineCetirizine

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2011

First Posted

May 18, 2015

Study Start

March 18, 2008

Primary Completion

April 30, 2008

Study Completion

April 30, 2008

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

JP(1)