Comparative in vivo evaluation of 2 Desloratadine 5 mg Tablet formulations.

Not Applicable

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

• Registration Number: IRCT20180620040164N61
• Lead Sponsor: Darou darman Arang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

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 the products tested.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Subjects who has used any prescription or OTC drugs 14 days prior to the initiation of study and unable to refrain from the concomitant medications.
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