Oral Bioavailability of Bilastine

Launched by FAES FARMA, S.A. · May 13, 2010

Keywords

ClinConnect Summary

Single centre, open label, cross-over, randomised, controlled, single dose study. The primary endpoint is the determination of plasma concentrations versus time (17 samples per subject at various time intervals after dosing) in order to assess the oral bioavailability of bilastine in healthy volunteers. Therefore the primary pharmacokinetic variable will be the area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞). Additionally the following pharmacokinetic variables will also be assessed: Cmax, AUC 0-t, tmax, Ae, Clr, t1/2. Additional objectives are to ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy volunteers of either sex aged from ≥ 18 to ≤ 35 years of age.
• • Body mass index between 19 and 29 Kg/m2.
• • Non smokers.
• • Judged to be in general good health based on medical history, physical examination and clinical laboratory tests.
• • Able to communicate well with the investigator and to comply with the requirements of the entire study.
• • Provision of written informed consent to participate.
• Exclusion Criteria:
• • Pregnant or breast-feeding women or with a positive pregnancy test. Subjects who do not agree to use an adequate method of contraception during the study.
• • Intake of another investigational medication in another clinical study within 4 months prior to the first study drug intake.
• • Regular use of any prescribed medication including medicinal herbs or OTC medication within 4 weeks of dosing.
• • A QTc\> 430 ms in males and a QTc\> 450 ms in females. A HR \<55 bpm.
• • Existence of any surgical or medical condition which, in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the IMP.
• • Known allergy/hypersensitivity to the study drug or its inactive ingredients.
• • Any clinical conditions or circumstances that in the opinion of the investigator would make the subject unsuitable for the study (e.g., hepatic impairment, renal impairment, mental impairment, cardiac disease).
• • Presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or HIV 1 or HIV 2 antibodies at screening.
• • Subjects who have taken metabolic or transporter inducers/inhibitors during the 3 months prior to inclusion in the study.
• • Donation or loss of greater than 200 mL of blood within 12 weeks before entry to the study.
• • Blood transfusion within the prior 6 months to inclusion.
• • Ingestion of citrus fruits and cranberries or any fruit juice within 7 days prior to first dose of study medication.
• • Known current alcohol or drug abuse.
• • Excessive consumption of xanthine containing foods or drinks.
• • Mentally disabled subjects or subjects who by official order have been institutionalised must be excluded from participation.