Last updated: 11/07/2018 10:28:51
Pharmacokinetic Study of Levocetirizine Oral Solution
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Pharmacokinetic Study of Levocetirizine Oral Solution-An open-label, randomized, cross-over study to evaluate the pharmacokinetics, the safety and tolerability of levocetirizine oral solution (5 mg) and cetirizine dry syrup (10 mg), following a single dose in Japanese healthy male subjects-
Trial description: This study will be a single center, open-label, randomized, single dose, in the fasted condition and 2-way crossover study to evaluate the pharmacokinetics, the safety and tolerability of levocetirizine oral solution 5 mg and cetirizine dry syrup 10 mg in Japanese healthy male subjects.Approximately 20 subjects will receive both treatments of levocetirizine oral solution 5 mg and cetirizine dry syrup 10 mg in the design. Serial pharmacokinetic samples will be collected and safety assessments will be performed following each dose.The primary objective of the study is to demonstrate the bioequivalence of levocetirizine in plasma, when given as levocetirizine oral solution 5 mg relative to cetirizine DS 10 mg in Japanese healthy male subjects.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
AUC(0-48) of levocetirizine
Timeframe: pre, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48h post dose
Cmax of levocetirizine
Timeframe: pre, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48h post dose
Secondary outcomes:
Adverse events
Timeframe: up to 48h post dose
Safety and tolerability
Timeframe: up to 48h post dose
Vital sign
Timeframe: up to 48h post dose
Body weight
Timeframe: up to 48h post dose
ECG
Timeframe: up to 48h post dose
Laboratory tests
Timeframe: up to 48h post dose
AUC(0-inf), MRT, tmax, and t1/2 of levocetirizine
Timeframe: pre, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48h post dose
Interventions:
Drug: Levocetirizine
Drug: Cetirizine
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Yohei Doi, Hiroko Ino, Katsutoshi Hara, Gosuke Honma, Hiroyuki Fukase.Comparison of levocetirizine pharmacokinetics after single doses of levocetirizine oral solution and cetirizine dry syrup in healthy Japanese male subjects.J Drug Asses.2014;3:38-42
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
cetirizine, levocetirizine
Collaborators
Not applicable
Study date(s)
May 2012 to June 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
20 - 55 years
Accepts healthy volunteers
Yes
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Japanese male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
- The subject is positive for syphilis, Hepatitis B surface antigen, Hepatitis C antibody, HIV1/2 antibody, or HTLV-1 antibody at screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Japanese male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
- Non-smoker or ex-smoker having ceased smoking for at least 6 months.
- Body weight => 50 kg and BMI within the range 18.5 – 25.0 kg/m2 at screening.
- A signed and dated written informed consent is obtained from the subject.
- Able to complete all study procedures and planned treatment periods.
- ALT, alkaline phosphatase and bilirubin =< 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
- Single QTcB < 450 msec at screening.
Exclusion criteria:
- The subject is positive for syphilis, Hepatitis B surface antigen, Hepatitis C antibody, HIV1/2 antibody, or HTLV-1 antibody at screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The subject has a history of allergic rhinitis.
- 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 a history or current conditions of drug abuse or alcoholism.
- A positive pre-study drug screen.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks. One drink is equivalent to 12 g of alcohol: 12 ounces (350 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product or a non-investigational drug within 4 months prior to the first dosing day in the current study.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
- Where participation in the study would result in donation of blood or blood products => 400 mL within 3 months or => 200 mL within 1 month.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2012-10-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 116459 can be found on the GSK Clinical Study Register.
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