None listed
Conditions
Interventions
Intervention1: Glyteine 400 mg capsules: Single dose of single unit of Glyteine 400 mg capsules will be administered orally.
Total duration of the study intervention is 02 days from check-in to end of
Sponsors
Biospecialties International Pty Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy human subjects (Male and/or Peri to Post menopausal Women) aged between 50 to 70 years (inclusive of both). 2. Volunteers with a BMI between 18.5-30.0 kg/m2 (inclusive of both) and body mass not less than 50.00 kg for male and 45.00 kg for females. 3. Volunteers willing to give written informed consent and adhere to all the requirements of this protocol. 4. Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the dosing.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Glyteine or Glutathione or any component of this medication. 2. Incapable of understanding the informed consent information. 3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological,dermatological, neurological or psychiatric disease or disorder. 4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study. 5.History of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis), diabetic pre-coma. 6. History or presence of alcoholism or drug abuse. 7. History or presence of Sulphur intolerance. 8. History or presence of asthma, urticaria or other allergic reactions. 9. History or presence of gastric and/or duodenal ulceration. 10. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion. 11. History or presence of cancer. 12. Difficulty with donating blood. 13. Use of any prescribed medication (including herbal remedies and vitamins) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies and vitamins) during one week prior to study initiation and throughout the study. 14. History or presence of smoking. 15. Volunteers consumed tobacco/tobacco containing products, pan or pan masala, gutkha, masala (containing betel nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study. 16. Volunteers consumed caffeine and/or xanthine- containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study 17. Major illness during the 90 days before screening. 18. Participation in a drug research study within 90 days of screening. 19. Donation of blood within 90 days of screening. 20. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL. 21. History or presence of easy bruising or bleeding. 22. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study. 23. Pregnant woman and nursing mothers. 24. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing. 25. Woman of child bearing age who do not agree to follow a reliable method of contraception during study period. 26. Difficulty in swallowing solids like capsules, tablets.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the time-dependent changes in glutathione concentrations in blood fractions following the oral administration of Glyteine 400 mg capsules.Timepoint: The pre-dose blood samples (04 mL each) will be collected at -12.00,-2.00, and 0.00 hours (basal/homeostasis levels) prior to Glyteine administration. Post-dose blood samples (04 mL each) will be collected at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00 and 7.00 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety & tolerability of orally administered Glyteine 400 mg capsules.Timepoint: Vital signs will be measured at the time of screening & Vital signs (body temperature, pulse rate & blood pressure) & questioning for well-being shall be before check-in, 01.00, 03.00 & 05.00 hours after dosing & before check-out of the stduy. Laboratory evaluation shall be done at the time of screening & at end of the study. | — |
Countries
India
Contacts
Public ContactDr D Tejo Swaroop Kumar
Noah Therapeutics Private Limited
Outcome results
None listed