To evaluate the efficacy of Odomos Spray & Lotion in twelve Healthy Adult Male Subjects.

To conduct Bioavailability studies on N,N-Diethylbenzamide (NNDB) from Odomos Spray and Lotion

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/014323

Enrollment

Registered

2018-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Odomos Spray: Odomos Spray was applied to 12 healthy volunteers, in a cross over design Control Intervention1: Odomos Lotion: Odomos Lotion was applied to 12 healthy volunteers, in a cr

Eligibility

Inclusion 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To assess bioavailability study of N,N-diethylbenzamide (NNDB) from Odomos Spray and Lotion.Timepoint: 0.00 hrs, 1.00 hrs, 2.00 hrs, 3.00 hrs, 4.00 hrs, 5.00 hrs, 6.00 hrs, 7.00 hrs, 8.00 hrs, 10.00 hrs, 12.00 hrs & 24.00 hrs	—

Secondary

Measure	Time frame
Safety of the Human SubjectsTimepoint: through out the study	—

Countries

India

Contacts

Public ContactDr S V Devasthale

Dabur India Limited

sanjay.devasthale@dabur.com01203378659

Outcome results