Phase 1 Study of Levocetirizine

Dermatitis Clinical Trial

Official title:

A Single Blind, Randomized, Single Oral Dose Study to Compare the Oral Disposition of Levocetirizine When Given Alone (5mg) or as the Racemate (Cetirizine 10mg), and to Investigate the Safety and Tolerability and the Pharmacokinetics of Levocetirizine and Cetirizine, Following a Single Dose in Healthy Japanese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447393
• Other study ID #: 111580
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2011
• Last updated: August 1, 2017
• Start date: March 18, 2008
• Est. completion date: April 30, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2008
• Est. primary completion date: April 30, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Body weight = 50 kg and BMI within the range 18.50-25.00 kg/m2 inclusive.

3. Non-smokers (at least 6 months).

4. 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

5. Normal 12-lead EGC finding at screening; QTc interval <450msec

6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.

2. The subject has an allergy for any drug or idiosyncrasy.

3. The subject has a history of allergic rhinitis.

4. 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.

5. 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.

6. The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months.

7. The subject has a history or current conditions of drug abuse or alcoholism.

8. 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).

9. The subject is positive for urine drug screening.

10. The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.

11. The subject has donated a unit of blood ">400mL" within the previous 4 months or ">200mL" within the previous 1 month.

Related Conditions & MeSH terms

• Dermatitis

Intervention

Drug:
• levocetirizine
levocetirizine
• cetirizine
cetiridine
• placebo
placebo

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Kagoshima

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Adverse events		predose,1,24 48 hours post-dose
Secondary	Changes in clinical laboratory tests		predose,24,48 hours post-dose
Secondary	Changes in vital signs		predose,1,24,48 hours post-dose
Secondary	Changes in 12-lead ECG.		predose,1,24,48 hours post-dose

External Links

•   Results for study 111580 can be found on the GSK Clinical Study Register.