None listed
Conditions
Interventions
Intervention1: HTYR091524 Capsule: ARM 1: 7 Healthy subjects administered with 1 HTYR091524 Capsule Once daily in empty stomach orally for a period of 14 days.
Intervention2: HTYR091524 Capsule: ARM 2
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the safety, tolerability of HTYR091524 in healthy volunteersTimepoint: Screening Visit- At entry visit Visit 1- Day 1 Visit 2- Day 7 Visit 3: Day 14 (End of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess Incidence of adverse events during the study periodTimepoint: Screening Visit- At entry visit Visit 1- Day 1 Visit 2- Day 7 Visit 3- Day 14 (End of study) | — |
Countries
India
Contacts
Public ContactDr Srikrishna
The Himalaya Drug Company
Outcome results
None listed