CompletedPhase 2ACTRN12609000702213

Study to compare the effects of taking 2.5mg of the antihstamine, Loratidine, four times a day with taking 10mg of Loratidine once a day in healthy volunteers

Maxiclear PD Study: A Double Blind, Randomised, Cross-over Trial to Compare the Pharmacodynamic Effects of Loratadine 2. 5 mg Four Times a Day with Loratadine 10 mg Once Daily in healthy volunteers.

Sponsor

AFT Pharmaceuticals Ltd

Enrollment

25 participants

Start Date

Sep 21, 2009

Study Type

Interventional

Conditions

Allergic rhinitis and relief of other allergic symptoms

Summary

Loratadine is usually given as a 10 mg dose once daily for the treatment of allergic condictions. However, based on pharmacokinetic principles it is likely that divided daily dosing such as 2.5 mg four times a day will also produce a similar effect on histamine effect compared with loratadine 10 mg once daily. This would enable smaller doses of loratadine to be combined with shorter acting agents such as phenylephrine.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two ways of taking the antihistamine loratadine — a small dose four times a day versus one larger dose once a day — to see if they work differently. It is for healthy men and women aged 18 to 50.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Loratadine 2.5 mg tablet four times a day orally for 72 hours. Participants who are on the this dose regimen in the first study phase will swap to the other dose regimen (loratadine 10 mg once daily)

Loratadine 2.5 mg tablet four times a day orally for 72 hours. Participants who are on the this dose regimen in the first study phase will swap to the other dose regimen (loratadine 10 mg once daily) in the second cross-over study phase. Washout is at least 10 days between these two study phases.

Locations(2)

Auckland, New Zealand

New Zealand

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ACTRN12609000702213