None listed
Conditions
Interventions
Intervention1: Liposomal Glutathione
: Dose:650mg, Dosage form: Capsule, Route of administration: Oral, Duration: Single oral dose in each period (3-period crossover study), Dosing condition: After o
Sponsors
SPECNOVA
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects must be healthy human male and female (non-pregnant) subjects. 2. Age should be between 18-45 years of age (both inclusive), weighing at least 50 kg. 3. Having a Body Mass Index (BMI) between 18.50 to 30 kg/m2 (both inclusive) at the time of screening. 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 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. 6. Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
Exclusion criteria
Exclusion criteria: 1. Subjects who are allergic to Glutathione products or any food or other drugs. 2. Subject with resting hypotension (BP less than 90 or 60) or hypertension (BP greater than 140 or 90) and pulse rate below 50 per min or 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. Subject who has a history of alcoholism, drug abuse or smoking. 7. Subjects who are hypersensitive to Heparin. 8. Subjects who participated in any other clinical study in the past three months. 9. Subject with clinically significant abnormal lab values, abnormal ECG, abnormal Chest X-ray (PA View). 10. Subject who has difficulty with donating blood. 11. Subject with history of difficulty in swallowing. 12. Subject who has unsuitable veins for repeated venipuncture. 13. Any exposure to general anesthesia with inhalation anesthetics within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in plasma GSH and GSSG levels measured by LC-MS/MS along with associated oxidative stress parameters including GSH:GSSG ratio and redox potential (Eh).Timepoint: 0 min, 30 min, 60 min, 90 min, 120 min, 3 h, 4 h, 6 h, 8 h, 12 h and 24 h. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To measure plasma 8-iso-PGF2alpha by LC-MS/MS Timepoints: 0, 4, 8, and 24 h. 2. To measure plasma cysteine (Cys) and cystine (CySS) by ELISA Timepoints: 0, 2, 4, and 24 h. 3. To measure VAS-F Score (0-100) Timepoints: 0 min, 30 min, 60 min, 120 min, 4 h, 24 h. 4. To monitor the safety and tolerability of a single dose of liposomal and non-liposomal Glutathione formulations.Timepoint: Day 0 and Day 1 of Period 1, 2 & 3;Safety Endpoints: 1.Changes in blood parameters assessed by blood tests Haematology and Biochemistry. 2. Adverse events (AEs), frequency and severity. 3. Number of subjects who discontinue study due to adverse events.Timepoint: Screening, Day 0 and Day 1 of Period 1, 2 & 3 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed