A study of a medicine named SCD-153, applied on the skin of Healthy Volunteers
- Registration Number
- CTRI/2023/10/059183
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1.Healthy male and non-pregnant, non-lactating female volunteers between 18-65 years (both inclusive) of age.
2.Voluntarily given informed consent to participate in this study.
3.Volunteers must have a 12-lead electrocardiogram (ECG), with no abnormalities considered to be clinically significant, as assessed by the Investigator/Sub-Investigator.
4.Clinical laboratory tests are within the normal laboratory reference ranges, or the abnormal values are assessed by the Investigator as clinically not significant.
5.The volunteer must be willing and able to comply with study-related instructions and restrictions and willing to remain confined at the clinic for the required duration during the study and to return to the clinic for the follow-up evaluation as specified in this protocol.
1.Participation in an investigational drug study within 90 days prior to screening.
2.Donated blood within 3 months prior to Screening.
3.Clinically significant abnormal physical examination findings.
4.History of drug and/ or alcohol abuse.
5.Has a history of, or any current systemic or dermatologic condition
6.The investigator determines volunteers to have any medical condition that could jeopardize their health or bias the results.
7.Volunteers who refuse to refrain from strenuous physical work or exercise from Screening until the end of the study visit.
8.Volunteers who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method