| Eligibility |
Inclusion Criteria:
Volunteers meeting all of the following criteria were considered for enrollment in the
study:
1. Male or female volunteer
2. Volunteer aged of at least 18 years
3. Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00
kg/m2
4. Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped
smoking for at least 12 months before day 1 of this study.
5. Availability for the entire study period
6. Motivated volunteer and absence of intellectual problems likely to limit the validity
of consent to participate in the study or the compliance with protocol requirements;
ability to cooperate adequately; ability to understand and observe the instructions of
the physician or designee
7. Clinical laboratory values within the laboratory's stated normal range; if not within
this range, they must be without any clinical significance
8. Have no clinically significant diseases captured in the medical history or evidence of
clinically significant findings on physical examination (including the examination of
the anterolateral thigh muscles) and/or clinical laboratory evaluations (hematology,
biochemistry, ECG and urinalysis)
9. Willingness to adhere to the protocol requirements as evidenced by the informed
consent form (ICF) duly read, signed and dated by the volunteer
Exclusion Criteria:
Volunteers presenting any of the following were not included in the study:
1. Females who are pregnant or are lactating
2. Females of childbearing potential who refuse to use an acceptable contraceptive
regimen throughout the entire duration of the study (from the screening visit until
study completion)
3. History of significant hypersensitivity to cetirizine or any related products
(including excipients of the formulations) as well as severe hypersensitivity
reactions (like angioedema) to any drugs
4. Presence of significant gastrointestinal, liver or kidney disease, or any other
conditions known to interfere with the absorption, distribution, metabolism or
excretion of drugs or known to potentiate or predispose to undesired effects
5. History of significant gastrointestinal, liver or kidney disease that may affect drug
bioavailability
6. Presence of significant cardiovascular, pulmonary, hematologic, neurological,
psychiatric, endocrine, immunologic or dermatologic disease
7. Suicidal tendency, history of or disposition to seizures, state of confusion,
clinically relevant psychiatric diseases
8. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 200 msec, QRS < 60
msec, QRS >110 msec and QTc > 440 msec) on the screening ECG or other clinically
significant ECG abnormalities
9. Known presence of rare hereditary problems of galactose and /or lactose intolerance
10. Maintenance therapy with any drug, or significant history of drug dependency or
alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or
chronic)
11. Any clinically significant illness in the previous 28 days before day 1 of this study
12. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450
(CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin,
fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP
enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and
St John's Wort), in the previous 28 days before day 1 of this study
13. Use of antihistaminic medication in the previous 7 days before day 1 of this study
14. Any history of tuberculosis and/or prophylaxis for tuberculosis
15. Positive urine screening of ethanol and/or drugs of abuse
16. Positive results to HIV, HBsAg or anti-HCV tests
17. Females who are pregnant according to a positive serum pregnancy test
18. Volunteers who took an Investigational Product (in another clinical trial) or donated
50 mL or more of blood in the previous 28 days before day 1 of this study
19. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical
studies, etc.) in the previous 56 days before day 1 of this study
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