CTRI/2024/12/078004尚未招募不适用
An open label, randomized, balanced, two treatment, one sequence, single period, parallel, single-dose oral bioequivalence study of Liposomal Glutathione powder sachet 2.5 gm (contains 01 gm of L-Glutathione) (LipoDuoâ„¢ Glutathione) (T) Manufactured by Samarth Biorigins LLP, India with Plain Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (R) Manufactured by Botanic Health Care Pvt. Ltd., India in normal healthy, adult human subjects under fasting condition.
Samarth Biorigins LLP1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年12月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax, AUC0-t & AUC0-inf
研究概览
简要总结
An open label, randomized, balanced, two treatment, one sequence, single period, parallel, single-dose oral bioequivalence study of Liposomal Glutathione powder sachet 2.5 gm (contains 01 gm of L-Glutathione) (LipoDuoâ„¢ Glutathione) (T) Manufactured by Samarth Biorigins LLP, India with Plain Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (R) Manufactured by Botanic Health Care Pvt. Ltd., India. To compare and assess the rate and extent of absorption of Liposomal Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (LipoDuoâ„¢ Glutathione) (T) Manufactured by Samarth Biorigins LLP, India with Plain Glutathione 2.5 gm powder sachet (contains 01 gm of L-Glutathione) (R) Manufactured by Botanic Health Care Pvt. Ltd., India under fasting conditions. To monitor the adverse events and to ensure the safety of the subjects following swallow of a single dose of test product of Liposomal Glutathione 2.5 gm powder sachet (contains 1 gm of L-Glutathione) (LipoDuoâ„¢ Glutathione) and reference product of Plain Glutathione 2.5 gm powder sachet (contains 1 gm of L-Glutathione) to adult human subjects under fasting condition under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Healthy, adult human, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
- •ï‚· Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both inclusive) at the time of screening.
- •ï‚· Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
- •ï‚· Able to comply with the study procedures, in the opinion of the Principal Investigator.
- •ï‚· Compliance with study specific restrictions and prohibitions.
- •ï‚· Able to give voluntary written informed consent for participation in the trial.
- •In case of Female subjects: ï‚· The Healthy adult female 18-45 years (both inclusive) of ages, perimenopause and post-menopausal female subjects shall be included in this study.
- •ï‚· Female subjects who are of child bearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra uterine device during the study.
- •ï‚· Female subjects who are tested negative for serum pregnancy test at the time of check-in.
- •ï‚· Female subjects who are tested negative for urine pregnancy test at the time of screening.
排除标准
- •Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •ï‚· History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
- •Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening.
- •ï‚· Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening.
- •ï‚· Pulse rate below 60 beats/minute or above 100 beats/minute at the time of screening.
- •ï‚· Body temperature below 96.2oF or above 99.8oF at the time of screening.
- •ï‚· SpO2 less than 94% at the time of screening.
- •ï‚· Ingestion of any medicine at any time within 14 days prior to IP administration in period I.
- •ï‚· Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
- •ï‚· Smokers and Alcoholics.
- •ï‚· History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
- •ï‚· An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
- •ï‚· The presence of clinically significant abnormal laboratory values during screening.
- •ï‚· Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
- •ï‚· A history of difficulty with donating blood or having donated blood in the preceding 90 days for males / 120 days for females prior to the start of the study.
- •ï‚· Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days for males / 120 days for females preceding the start of the study.
- •ï‚· Difficulty in swallowing dispersed solution.
- •ï‚· Positive HIV, VDRL/RPR, Hepatitis B and C tests.
- •ï‚· Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
- •ï‚· Female volunteers who are of child bearing potential but not sterilized or not willing to use contraceptives.
- •ï‚· Female Subjects with depot injections or implants within past 6 months.
- •ï‚· History of undiagnosed vaginal bleeding (for females only).
- •ï‚· Female subjects who demonstrates a positive pregnancy during screening or currently breast-feeding.
- •Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
- •ï‚· Pregnant and lactating women.
结局指标
主要结局
Cmax, AUC0-t & AUC0-inf
时间窗: -12.00, - 02.00, 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00 and 24.00 Edit || Delete
次要结局
- Tmax, Kel, t½, AUCExtrapolated%, CL and Vz(-12.00, - 02.00, 00.00, 00.25, 00.50, 01.00, 01.50, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00 and 24.00)
研究者
Dr Divya A MD
M/s Notrox Research Pvt Ltd (NRPL)
研究点 (1)
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