healthy volunteers betahistine dihydrochloride Bioequivalence
Conditions
Interventions
generic formulation of betahistine dihydrochloride ,original formulation of betahistine dihydrochloride
Experimental Drug,Active Comparator Drug
Stei®,Serc®
Sponsors
Somruedee Chatsiricharoenkul
Siriraj Clinical Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy Thai volunteers with a body mass index between 18-25 kg/m2 In good physical condition by clinical screening included history taking, physical examination and the following laboratory tests: complete blood count, blood urea nitrogen, serum creatinine, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, fasting blood sugar, urinalysis and hepatitis B surface antigen.
Exclusion criteria
Exclusion criteria: - Pregnant or lactating women or positive pregnancy test women - Allergy to the study drug - Volunteers who used any drugs, food supplements, vitamins, mineral, herbal remedies, contraceptives hormonal within 14 days before study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of 2-pyridylacetic acid (2-PAA), a major metabolite of betahistine Blood samples were obtained at pre-dose and over 14 hours after dosing. liquid chromatography with tandem mass spectrometry (LC-MS/MS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability throughout the study Adverse events were monitored and recorded based on volunteer interview and physical examination. | — |
Countries
Thailand
Contacts
Public ContactSomruedee Chatsiricharoenkul
Department of pharmacology
Outcome results
None listed