None listed
Conditions
Interventions
Intervention1: HQAP061801: This is an open label, two arm clinical study to evaluate the safety and tolerability of
HQAP061801 in healthy adult volunteers aged between â?¥18 to â?¤ 60 years. In the p
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy male and female adult volunteers. 2) Aged >=18 to 3) Subjects willing to sign the informed consent. 4) Subjects to be refrained to take any other similar kind of intervention during the study period
Exclusion criteria
Exclusion criteria: 1) Subjects clinically diagnosed with any clinically significant systemic disorder. 2) Subjects on any other nutritional supplements. 3) A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the test products. 4) Genetic and Endocrinal disorders. 5) Has participated in a similar clinical investigation in the past four weeks. 6) Subjectâ??s parents who refused to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess safety and tolerability of HQAP061801 in Healthy Adult Volunteers.Timepoint: Subjects will be followed up and the clinical assessment from baseline on visit days: Visit 0- At entry visit, Screening, Visit 1- At the end of Day 3, Visit 2 â?? At the end of Day 7 (End of the Study) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the incidence of adverse events reported or observed during the study period and overall compliance to the study intervention.Timepoint: Subjects will be followed up and the clinical assessment from baseline on visit days: Visit 0- At entry visit, Screening, Visit 1- At the end of Day 3, Visit 2 â?? At the end of Day 7 (End of the Study) | — |
Countries
India
Contacts
Public ContactDr Palaniyamma
The Himalaya Drug Company
Outcome results
None listed