To evaluate the efficacy of Odomos Spray & Lotion in twelve Healthy Adult Male Subjects.
- Registration Number
- CTRI/2018/05/014323
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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.
1.History of hypersensitivity to the study formulations or related products.
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 of this study.
6.Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
7.Participation in a clinical trial with an investigation drug within 90days preceding day 1 of the current study.
8.Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
9.Use of any systemic medication (including OTC preparations) within 14 days proceeding day 1 of this study.
10.HIV and Hepatitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method