Pilot study to test and validate the applicability of a bioanalytical assay for betahistine in plasma after administration of a single dose betahistine 24 mg IR tablet
Not Applicable
Completed
- Registration Number
- CTRI/2011/08/001934
- Lead Sponsor
- Abbott Healthcare Products BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
�BMI 18 - 28 kg/m2
Exclusion Criteria
?Subjects who participated in a previous betahistine trial
?Subjects who can not communicate reliable with the investigator
?Subjects who are unlikely to co-operate with the requirements of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, tmax, λz, t1/2, AUC0-t and AUC for both betahistine and metabolite 2-Pyridyl Acetic Acid ; <br/ ><br>CL/F and Vz/F for betahistine only <br/ ><br>Timepoint: Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).
- Secondary Outcome Measures
Name Time Method adverse event and concomitant medication recording.Timepoint: Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).;Safety assessments including medical and drug history, physical examination, vital signs, 12-lead ECG, safety laboratory tests, <br/ ><br>viral serology, urine drug screen / alcohol breath testTimepoint: Blood samples for plasma betahistine / 2-PAA PK profiles will be taken on Day 1 / 2 (pre-dose, 0.050, 0.083, 0.167, 0.250, 0.333, 0.416, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 15.000, 18.000 and 24.000 hours post-dose).