Comparative bioequivalence study of Loratadine 10 mg Tablet of Karen Pharma and Food Supplement Co. and Claritine® of NBAYER as reference in 24 healthy male under fasting.

Karen Pharma and Food Supplement Co.0 sites24 target enrollmentStarted: TBDLast updated: March 13, 2023

Trial Snapshot

No summary available.

•Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
•Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
•Subjects with normal vital signs.
•Subjects who agree with patient consent form.

•Subjects with known allergy to loratadine.
•Had history of hypertension.
•Had Concurrently used enzyme modifying drugs especially erythromycin, MAO inhibitors, ketoconazole, and cimetidine.
•Had recent history of abdominal pain, epistaxis or sleep disturbances.
•Had history of any psychiatric illness, which may impair the ability to provide, written informed consent.
•Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
•Consumption of enzyme modifying drugs within 30 days prior to Day 1 of this study.
•History of alcohol or drug abuse.
•Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
•A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.

Sponsor

Karen Pharma and Food Supplement Co.