Phase 1 Safety study for thyroid health
- Registration Number
- CTRI/2019/03/017887
- 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
1.Healthy male or female volunteers.
2.Aged between 18-65 years.
3.Subjects willing to sign informed consent and follow the study procedure.
4.Has not participated in a similar investigation in past 2 weeks.
1.Subjects with any clinically significant serious cardiovascular, cerebrovascular, respiratory, liver, renal, congenital, psychiatric, metabolic, endocrinal or any other disorder.
2.A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the test products
3.Alcoholics and smokers
4.Pre-existing systemic disease necessitating long-term medications.
5.No other drugs were to be taken during the course of the study.
6.Pregnant & breast-feeding women.
7.Subjects unwilling to provide informed consent or abide by the requirements of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the safety, tolerability of HTYR091524 in healthy volunteersTimepoint: Screening Visit- At entry visit <br/ ><br>Visit 1- Day 1 <br/ ><br>Visit 2- Day 7 <br/ ><br>Visit 3: Day 14 (End of study) <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess Incidence of adverse events during the study periodTimepoint: Screening Visit- At entry visit <br/ ><br>Visit 1- Day 1 <br/ ><br>Visit 2- Day 7 <br/ ><br>Visit 3- Day 14 (End of study)