None listed
Conditions
Interventions
Intervention1: Liposomal Glutathione 2.5 gm powder sachet (contains 01
gm of L-Glutathione) (LipoDuo™ Glutathione).: After an overnight fasting of at least 10.00 hours, a single dose of Liposomal Glut
Sponsors
Samarth Biorigins LLP
Eligibility
Inclusion criteria
Inclusion criteria: Healthy, adult human, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening. ? Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both inclusive) at the time of screening. ? Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings. ? Able to comply with the study procedures, in the opinion of the Principal Investigator. ? Compliance with study specific restrictions and prohibitions. ? Able to give voluntary written informed consent for participation in the trial. In case of Female subjects: ? The Healthy adult female 18-45 years (both inclusive) of ages, perimenopause and post-menopausal female subjects shall be included in this study. ? 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. ? Female subjects who are tested negative for serum pregnancy test at the time of check-in. ? Female subjects who are tested negative for urine pregnancy test at the time of screening.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug. ? 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. ? Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening. ? Pulse rate below 60 beats/minute or above 100 beats/minute at the time of screening. ? Respiratory rate below 12 or above 20 breaths per minute at the time of screening. ? Body temperature below 96.2oF or above 99.8oF at the time of screening. ? SpO2 less than 94% at the time of screening. ? Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case subject selection will be at the discretion of the Principal Investigator. ? Habit of consuming high caffeine (more than 5 cups of coffee or tea/day). ? Smokers and Alcoholics. ? History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in. ? 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. ? The presence of clinically significant abnormal laboratory values during screening. ? Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test. ? 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. ? 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. ? Difficulty in swallowing dispersed solution. ? Positive HIV, VDRL/RPR, Hepatitis B and C tests. ? 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. ? Female volunteers who are of child bearing potential but not sterilized or not willing to use contraceptives. ? Female Subjects with depot injections or implants within past 6 months. ? History of undiagnosed vaginal bleeding (for females only). ? 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. ? Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t & AUC0-infTimepoint: -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 24.00Edit || Delete | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Kel, t½, AUCExtrapolated%, CL and VzTimepoint: -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 | — |
Countries
India
Contacts
Public ContactDr Divya A MD
M/s Notrox Research Pvt Ltd (NRPL)
Outcome results
None listed