Comparative in vivo evaluation of 2 Loratadine 10 mg Tablet formulations.

Not Applicable

Conditions: Allergic rhinitis, unspecified.
Allergic rhinitis, unspecified
J30.9

Registration Number: IRCT20180620040164N41

Lead Sponsor: Karen Pharma and Food Supplement Co.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Male

Target Recruitment: 24

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: Before intervention and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post intervention in each period. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).

Secondary Outcome Measures

Name	Time	Method
AUC (Area Under the Concentration-Time Curve). Timepoint: Before intervention and then at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 & 72 hours post intervention in each period. Method of measurement: using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).