Phase I safety study of HQAP061801 in Healthy Adult Volunteers
Phase 1
- Registration Number
- CTRI/2019/03/017972
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Healthy male and female adult volunteers.
2)Aged >=18 to <= 60 years.
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br/ ><br>Visit 0- At entry visit, Screening, <br/ ><br>Visit 1- At the end of Day 3, <br/ ><br>Visit 2 â?? At the end of Day 7 (End of the Study) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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: <br/ ><br>Visit 0- At entry visit, Screening, <br/ ><br>Visit 1- At the end of Day 3, <br/ ><br>Visit 2 â?? At the end of Day 7 (End of the Study) <br/ ><br>