CTRI/2018/03/012451
Completed
Phase 1
Patch Test (Skin Irritation)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dabur India Limited
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the written
- •informed consent.
- •2\. Normal findings in the physical and clinical examinations.
- •3\. Clinical Laboratory values within 10% above or below the laboratoryâ??s stated normal range, unless the investigators along with physicians decide that they are not clinically significant and record this fact on the case report form.
- •4\. A Non\-Smoker.
- •5\. Asian males of Indian origin.
Exclusion Criteria
- •1\. History of hypersensitivity to the study formulations or related
- •2\. Significant history or presence of psychiatric, gastro intestinal, liver
- •or kidney disorder/impairments, or any other conditions known to
- •interfere with the absorption, distribution, metabolism or excretion of
- •common medications.
- •3\. Significant history of asthma, chronic bronchitis or other
- •bronchospastic condition.
- •4\. Significant history or presence of glaucoma, cardiovascular or
- •hematological disease.
- •5\. Any clinically significant illness during the 4 weeks prior to day one
Outcomes
Primary Outcomes
Not specified
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