A double blind, randomized, single dose, three treatment, three way crossover, oralbioavailability study of investigational product containing ß- analine in healthy, adult, humanparticipants under fasting conditions.

atural Alternatives International0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1.Normal healthy adult male and female human subjects of age between 18-65 years with a body mass index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2
•2.Subject agrees avoid ß-alanine containing medications and dietary supplements from screening until last visit.
•3.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
•4.Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 29 days of check in.

•1.Evidence of allergy or known hypersensitivity to ß-alanine or other related drugs or other related drugs.
•2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
•3.Any major illness in the last three months or any significant ongoing chronic medical illness.
•4.Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
•5.History of alcohol addiction or abuse.
•6.Malabsorption syndrome that affects ß-alanine metabolism.

发起方

atural Alternatives International