A double blind, randomized, single dose, three treatment, three way crossover, oral bioavailability study of investigational product containing β- analine in healthy, adult, human participants under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To evaluate the oral bioavailability of investigational product (β-alanine complex (400 mg)), reference product I (Conventional β-alanine (400 mg)) and reference product II (Conventional β-alanine (1200 mg)) in healthy, adult, Human participants under fasting conditions
研究概览
简要总结
β-Alanine (or beta-alanine) [3-aminopropanoic acid] is a naturally occurring beta amino acid, which is an amino acid in which the amino group is attached to the β-carbon. BA, a precursor of carnosine, has been shown to increase intracellular levels of carnosine and reduce acidosis during high-intensity exercise. This indicates that carnosine may act as a physiologically meaningful physiochemical buffer. In normal conditions, rate of BA production is relatively low and serum BA concentration is undetectable. If there is an increase in BA to a detectable level in the bloodstream, there may also be a subsequent increase in carnosine in the muscle. This increase has been considered as enhancing blood buffering capacity and decreasing neuromuscular fatigue. Thus, the rationale of supplementing with BA as an ergogenic aid has often been described to increase athletic performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 β-alanine metabolism.
结局指标
主要结局
To evaluate the oral bioavailability of investigational product (β-alanine complex (400 mg)), reference product I (Conventional β-alanine (400 mg)) and reference product II (Conventional β-alanine (1200 mg)) in healthy, adult, Human participants under fasting conditions
时间窗: day 1
次要结局
- To monitor the adverse events and to ensure the safety of the subjects.(da1, day30)
研究者
Dr Ambanna Gowda
Unitree Health Care Diagnostics