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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000702213

Acronym

Maxiclear PD Study

Enrollment

Registered

2009-08-13

Start date

2009-09-21

Completion date

2009-10-22

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy volunteers, males and females aged 18-50 years. Females must be sterile or using adequate contraception.

Exclusion criteria

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.

Outcome results