A prospective, double-blind, randomized, cross-over, three arm, three treatments, three period, placebo-controlled study to evaluate the pharmacokinetic effects of Paraxanthine (PX) in comparison to that of Caffeine (CF) in otherwise healthy volunteers.
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- M/S. INGENIOUS INGREDIENTS
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To determine the bioavailability of Paraxanthine (PX) and Caffeine (CF) in plasma
概览
简要总结
Caffeine is an odorless white powder or white glistening needles, bitter in taste. Solutions in water are neutral to litmus. (NTP, 1992). Caffeine is a trimethyl xanthine in which the three methyl groups are located at positions 1, 3, and 7. A purine alkaloid that occurs naturally in tea and coffee. It has a role as a central nervous system stimulant, a phosphoric diester hydrolase inhibitor, an adenosine receptor antagonist, a non-specific serine/threonine protein kinase inhibitor, a ryanodine receptor agonist, a psychotropic drug, a diuretic, a food additive. After ingestion, caffeine is quickly absorbed from the gastrointestinal tract into the circulatory system. The maximum plasma concentration is reached after 30-60 minutes from consumption. maximum plasma concentrations reached between 15 and 120 min have been reported. Paraxanthine, the key metabolite of caffeine, has a similar chemical structure and half-life to those of caffeine and is easily measured in serum and urine. About 60% of orally ingested paraxanthine is excreted unmodified. Mechanisms of paraxanthine’s potential ergogenic effects include (A) an increase in plasma free fatty acids, a source of fuel that the body can utilize to produce energy, (B) a reduction of plasma K+ concentrations which may attenuate the onset of skeletal muscle fatigue, and (C) an increase in calcium ions in the skeletal muscle, which is involved in muscle contractions. Mechanisms of paraxanthine’s potential ergogenic effects include (A) an increase in plasma free fatty acids, a source of fuel that the body can utilize to produce energy, (B) a reduction of plasma K+ concentrations which may attenuate the onset of skeletal muscle fatigue, and (C) an increase in calcium ions in the skeletal muscle, which is involved in muscle contractions.
研究设计
- 研究类型
- Ba/be
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Subjects must be healthy human male and female 50 percentage each subjects 2 Age should be between 18 to 45 years of age both inclusive weighing at least 50 kg 3 BMI less than 30 kg per m2 4 Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol 5 Subjects willing to give consent for CYP1A2 genotyping 6 Subjects with no evidence of underlying disease during the pre study screening They must be healthy as determined by medical history and physical examination ECG Chest X ray PA View and laboratory tests performed within 7 days prior to the commencement of the study 7 Subjects whose screening laboratory values are within normal limits or considered by the physician or Principal Investigator to be of no clinical significance.
排除标准
- •1 Subject has a known allergy or sensitivity to any ingredient in the test product 2 Subject with resting hypotension BP less than 90 per 60 or hypertension BP more than 140 per 90 and pulse rate below 50 per min and more than 100 per min 3 Subject with or a prior history or presence of significant cardiovascular pulmonary hepatic renal hematological gastrointestinal endocrine immunologic dermatologic neurological musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in housing.
- •4 Subjects with a history of MI Stroke Peripheral Arterial Disease GI Bleeding Hepatic Impairment Asthma Renal Impairment Epilepsy and Intracranial hemorrhage 5 Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study 6 Subjects who are hypersensitive to Heparin 7 Subjects who participated in any other clinical study in the past three months 8 Subject with clinically significant abnormal lab values or abnormal ECG or abnormal Chest X-ray PA View 9 Subject who has difficulty with donating blood 10 Subject with history of difficulty in swallowing 11 Subject who has unsuitable veins for repeated venipuncture.
结局指标
主要结局
To determine the bioavailability of Paraxanthine (PX) and Caffeine (CF) in plasma
时间窗: 0 min, 10min, 20min, 40min, 60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr and 24hrs
by LC-MS/HPLC.
时间窗: 0 min, 10min, 20min, 40min, 60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr and 24hrs
次要结局
- To evaluate the effects of the test product on overall mood through caffeine(research visual analogue scale (Caff-VAS))
- Changes in blood parameters assessed by blood tests: Hematology,(Biochemistry and Urine analysis)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt. Ltd