None listed
Conditions
Interventions
Intervention1: NR-INF-02 (1000mg): One tablet of 500mg twice daily orally for a period of 84 days
Intervention2: NR-INF-02 (2000mg): Two tablets of 500mg twice daily orally for a period of 84 days
Con
Sponsors
Natrural Remedies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject must be a healthy adult male or female, 18-65 years of age (inclusive). 2.Subject should have a Body Mass Index of 18.5 kg/m2 and 24.9 kg/m2 with body weight at least 55 kg for men and at least 48 kg for women. 3.Female subjects of childbearing potential must be using a medically acceptable form of birth control. 4.Female subjects must have a negative pregnancy test result . 5.Subject should have clinically insignificant ECG and vital signs. 6.Screening or baseline hematology and clinical chemistry measures should be within normal range. 7.Willing to sign the informed consent and comply with study procedure.
Exclusion criteria
Exclusion criteria: 1.Female subjects, who are pregnant, breast feeding or planning to become pregnant. 2.Subject has a history of hypersensitivity or idiosyncratic reaction to active or inactive ingredient in the study medication or any other related product. 3.Concomitant medications (especially anticoagulants and aspirin) or herbal supplements. 4.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary,gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies. 5.Subject has a history of alcohol or substance abuse within the last 5 years. 6.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 7.Concomitant medications (especially anticoagulants and aspirin) or herbal supplements. 8.Positive HIV serology. 9.Participation in any other trials involve investigational or marketed products within 30days prior to the Screening Visit.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in â?¢Vital signs Timepoint: Screening visit(-7 to 0 day),Randomization visit(day0),Visit 2(day 42),Visit 3(day84) | — |
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in â?¢Incidence of adverse events and â?¢Clinical laboratory parameters Timepoint: Screening visit(-7 to 0 day),Randomization visit(day0),Visit 2(day 42),Visit 3(day84) | — |
Countries
India
Contacts
Public ContactMr Sanjib Panda
Natural Remedies Private Limited
Outcome results
None listed