None listed
Conditions
Interventions
Intervention1: Sodium Copper Chlorophyllin of IDRS Labs Pvt. Ltd. Bengaluru, India: Dose: 1500 mg, 3000 mg, 6000 mg given in two divided dosage
Frequency: morning & evening
Duration of treatment: One day
Control Intervention1: NA: NA
Sponsors
IDRS Labs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: i. Non-smoker, Healthy, adult, human male volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India. ii. Having a Body Mass Index (BMI) between 18.5 to 24.9 (both inclusive), calculated as weight in kg/height in meter square. iii. Have no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings. iv. Able to understand and comply with the study procedures, in the opinion of the investigator. v. Able to give voluntary informed consent for participation in the trial.
Exclusion criteria
Exclusion criteria: i. Known hypersensitivity or idiosyncratic reaction to Sodium Copper Chlorophyllin or to any of its excipients or any drug or any substance. ii. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. iii. Ingestion or Use of any medication [prescribed & over the counter (OTC) medication including herbal remedies] at any time within 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator. iv. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID (i.e. ibuprofen, aspirin) induced urticaria. v. Consumption of grapefruits or grapefruits products within a period of 72 hours prior to dosing. vi. A recent history of harmful use of alcohol(less than 2 years) vii. Smokers, or who have smoked within last six months prior to start of the study. viii. The presence of clinically significant abnormal laboratory values during screening. ix. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. x. History or presence of psychiatric disorders. xi. A history of difficulty with donating blood. xii. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. xiii. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. xiv. A positive test result for HIV antibody (I & II). xv. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug. In any such case subject selection will be at the discretion of the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of Chlorophyllin.Timepoint: During entire duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| The pharmacokinetics, modulation of pharmacodynamic markers and food effect of Chlorophyllin (CHL)Timepoint: Day 1- Day 7 | — |
Countries
India
Contacts
Public ContactMr Shivkumar Madki
Tata Memorial Centre
Outcome results
None listed