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.
AFT Pharmaceuticals Ltd
25 participants
Sep 21, 2009
Interventional
Conditions
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
Inclusion Criteria2
- Healthy volunteers, males and females aged 18-50 years.
- Females must be sterile or using adequate contraception.
Exclusion Criteria2
- Participants who have any concomitant medications currently, or in the 7 days prior to the start of the each study phase. The only exception are oral contraceptives, ibuprofen and paracetamol.
- Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant's best interests to participate in this study.
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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) in the second cross-over study phase. Washout is at least 10 days between these two study phases.
Locations(2)
View Full Details on ANZCTR
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ACTRN12609000702213