CTRI/2023/11/059982已完成不适用
A pilot two arm, two period, cross over, open label, Single-centre, comparative trial to Investigate the change in oral bioavailability of Nicotinamide Mononucleotide (NMN, 500mg) when 5mg Bioperine is added to NMN 500mg in normal healthy volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To evaluate the change in bioavailability between two different formulations - NMN Arm (A) vs NMN with Bioperine between Arm (B)
研究概览
简要总结
Nicotinamide Mononucleotide is a derivative of Niacin (Vitamin B3) and is precursor to NAD+ which is essential co enzyme for several biological process involving energy metabolism and DNA repair. The absorption and bioavailability of NMN and its analogues greatly varies from person to person because of PK and PD parameters. The present study is aimed to improve the bioavailability and pharmacodynamic changes in normal healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Male subjects and/or non-pregnant, non-lactating female subjects of childbearing potential and/or female subjects who have attained menopause.
- •Subject of age 18 to 45 years and above with BMI of 18.50 – 30.0 Kg/m
- •Subjects with normal vital parameters Blood Pressure (120/80 to 139/89 mmHg), pulse rate (70-100 beats/min) and temperature (97.00F-99.00F) and general clinical examination or those considered not clinically significant as decided by the investigator.
- •Subject who agree not consume coffee, tea, cola, chocolate or any other xanthine containing food or drinks within 3 days prior to start of the study and during the washout period.
- •Subject with no current or recent (within 2 weeks before randomization) treatment with any another investigational product.
- •Negative pregnancy test for females and does not plan to become pregnant during course of the study.
排除标准
- •History of uncontrolled systemic diseases such as cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders, based on clinical investigator’s judgment.
- •History of chronic alcoholism/ chronic smoking/ drug of abuse.
- •Subjects with hypersensitivity to NMN and BIOPERINE or any of the excipients.
- •Pregnant or lactating female subjects.
- •History of consumption of tobacco containing products within 48 hours prior to the proposed time of dosing.
- •Subjects who are positive for hepatitis B, anti-hepatitis C and Human Immunodeficiency Virus (HIV 1&2).
- •Present or past history of intake of vitamins & mineral supplements, herbal medicines or any prescription drugs other than the drugs already included in patient’s treatment regimen or over the counter (OTC) medicines within 14 days which can potentially alter/interfere / modify the PK parameters of NMN and BIOPERINE or any other medication judged to be clinically significant by the investigator.
- •Subjects who had donated blood/had any other blood loss over 01 unit of blood during the last 01 months before study initiation.
结局指标
主要结局
To evaluate the change in bioavailability between two different formulations - NMN Arm (A) vs NMN with Bioperine between Arm (B)
时间窗: Day-1 and Day-5
次要结局
- To assess the efficacy, safety and tolerability of the above formulations in the study subjects by monitoring the incidence of any adverse events (AEs)(Screening to Day-5)
研究者
Dr T Shivakumar
TR Super Speciality Hospital
研究点 (1)
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