A randomized, double-blind, single oral dose, two-period, two-treatment, two-sequence crossover comparative pharmacokinetic study of Test product ‘Glutathione loaded in Zeal platform’ of Aurea Biolabs (P) Limited with Reference product ‘Plain glutathione’ of Wonder Ingredient in 16 healthy, adult, human subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
**Study Title:**A randomized, double-blind, single oral dose, two-period, two-treatment, two-sequence crossover comparative pharmacokinetic study of Test product ‘Glutathione loaded in Zeal platform’ of Aurea Biolabs (P) Limited with Reference product ‘Plain glutathione’ of Wonder Ingredient in 16 healthy, adult, human subjects under fasting condition.
I****ndication
· Support antioxidant defense and reduce oxidative stress.
· Promote healthy skin tone and brightness by reducing melanin synthesis.
· Support liver function and detoxification.
· Improve overall immune health and cellular protection.
Study Objective
Primary objective: To measure and compare the pharmacokinetics of Test with reference under fasting condition in healthy, adult, human subjects in a randomized cross over study.
Secondary objective: To evaluate Renal Function Test and Liver Function Test.
Screening procedures Screening procedures will be performed within 21 days prior to check-in of period-I and screening will include registration/identification in biometric system, obtaining written screening consent, demographic parameters, medical history, physical examination, vital signs measurements (blood pressure, pulse rate, temperature and respiratory rate), 12-lead ECG recording, laboratory investigations [hematology, biochemistry, serology and urine analysis etc.] and evaluation of applicable inclusion and exclusion criteria.
Sampling Schedule In each period, a total of 8 blood samples (04 ml each) will be collected from each subject in vacutainers (containing K2EDTA as an anticoagulant).
Sampling points: Pre-dose at 0.00 and 01.00, 02.00, 04.00, 06.00, 12.00, 18.00 and 24.00 hours post-dose.
Total Blood loss For each male subject, the total volume of blood collection (including pre dose & post study blood sample) will be approximately 83 mL combining all the periods.
Sample Processing For each time point, blood will be collected using a syringe and immediately transferred into K2-EDTA vacutainers containing a stabilizer to prevent oxidation of reduced glutathione (GSH) to oxidized glutathione (GSSG). Anyone of the below two can be used:
- N-Ethylmaleimide (NEM): 100 µL of a 200 mM NEM solution in ammonium formate buffer will be pre-aliquoted in the vacutainer. or
- Metaphosphoric Acid (MPA): 100 µL of a 50% MPA solution will be aliquoted in the vacutainer.
After collection, samples will be gently mixed by inversion. The samples will be stored upright in a deep freezer set at -20 ± 5ºC. Samples will be transferred to the bioanalytical department at the end of clinical phase of the study. Samples in the bioanalytical department will be stored at -20 ± 5ºC deep freezer till analysis and during archival period. Second aliquot (about 02 mL) will be made from the sample and stored. Analyte(s) and Analytical Method Total Glutathione in whole blood samples will be quantified using bioanalytical LC-MS/MS method.
Pharmacokinetic Parameters Primary PK parameters: Cmax and AUC0-t
Secondary PK parameters: Tmax, Kel, T1/2, AUCextrap, AUCratio and AUC0-inf
Pharmacokinetic parameters and descriptive statistics will be evaluated using Phoenix® WinNonlin® Software Version 8.4 (Certara Inc., USA) or latest version.
Statistical Analysis Statistical analysis will be performed by using SAS® software version 9.4 (or higher version).
The ln-transformed pharmacokinetic parameters [Cmax and AUC0-t] will be analyzed using ANOVA model with the main effect of treatment, period, sequence and subject nested within sequence as fixed effects. The Intra subject CV, Power, Ratio analysis and 90% confidence interval for the ratio of the geometric least squares mean will be computed for ln-transformed pharmacokinetic parameters [Cmax and AUC0-t]. Comparative pharmacokinetic data will be presented for test vs reference
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subject should provide written informed consent.
- •Subject must be a healthy adult within 25.00-50.00 years of age (both inclusive).
- •Subject should have a Body Mass Index of 18.50 kg/m2 and 29.99 kg/m2 (Both Inclusive).
- •Subject should have within the normal range or not clinically significant for Hematology, chemistry and urinalysis.
- •5.Subject must be of normal health as determined by medical and surgical history and physical examination performed within 21 days prior to the dosing of Period.
- •Subject should have normal ECG and vital signs.
- •Subject who is Non-smoker.
- •Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody and Syphilis.
- •Negative urine test for drug of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check-in during each period).
- •Negative Urine test for alcohol consumption (to be performed on the day of check-in during each period).
排除标准
- •Personal or family history of skin cancer, especially melanoma
- •Consumption of any preparations containing glutathione within 1 month of enrollment
- •Use of any topical skin brightening or whitening preparations containing glutathione within 1 month of enrollment
- •A pregnant or breastfeeding mother
- •Personal history of food ingredient allergy or skin disorder due to side effects of oral therapy
- •Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
- •Subject has a history of alcohol, smoking or other food ingredient abuse in the past year.
- •Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP 140 and/or diastolic BP 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
- •Subject has a known allergy or sensitivity to any ingredient in the test product
- •Subject has any medical condition or uses any food ingredient, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •Subject has a history of difficulty swallowing large pills or tablets.
- •Investigator is uncertain about subject’s capability or willingness to comply with the protocol requirements
- •Subject is incapable of understanding the informed consent.
- •Intake of any prescription food ingredients within 14 days prior to check-in and throughout the study, and/or over-the counter (OTC) & herbal food ingredients, CYP3A4 inhibitors/ alpha-blockers/ Food ingredients Metabolized by CYP2D6/ digoxin & warfarin within 7 days prior to check-in and / or intake of any food ingredient in the past for long term that could affect the kinetics or dynamics of study food ingredients in view of investigator.
- •Subject has a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
- •Alcohol consumers, intake of alcohol 07 days prior to check-in and/or found positive in Urine test for alcohol consumption during check-in of each period.
- •Consumption of grapefruit juice and /or grapefruit at least 72.00 hours prior to period I check-in through the last PK sample collection of the last period of the study.
- •History of habituation to or consumption of caffeine and /or xanthine products, and tobacco containing products within 72.00 hours prior to check-in and inability to withhold the intake during the in house stay.
- •Subject has clinically significant abnormal values of laboratory parameters.
- •Subject has participated in any other clinical investigation using experimental food ingredient or had bled more than 350 mL in the past 90 days.
- •Subject is unable to or unlikely to be compliant with protocol requirements or restrictions.
- •Subject, in whom study food ingredient is contraindicated for medical reasons
- •Subject is intolerant to venipuncture.
研究者
Dr K Sudhakar Reddy
IndiGlobal Labs Private Limited