None listed
Conditions
Interventions
Intervention1: Active-SCD-153: frequency:
Single topical application
route
of administration: topical duration of study: approximately 14 days
Control Intervention1: Vehicle: frequency: Single topical
Sponsors
Sun Pharma Advanced Research Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety by assessing the incidence & severity of AEs, vital signs, clinical laboratory assessments, physical examination & local tolerability assessmentsTimepoint: upto Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the plasma pharmacokinetic parameters - Cmax, Tmax, AUC0-24, AUC0-t, AUC0-inf, t1/2 2. To assess the urinary pharmacokinetic parameters - cumulative amount eliminated in the urine (Ae), a fraction of the dose eliminated in the urine (Fe), & Renal clearance (CLr) Timepoint: upto Day 4 | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar
Sun Pharma Advanced Research Limited
Outcome results
None listed