This is trial that has an objective of evaluating the local and systemic safety and tolerability of the new steroid, that is administered as a nasal spray, in healthy male volunteers.
- Registration Number
- CTRI/2011/03/001651
- Lead Sponsor
- Atul Raut MD PhD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Availability of subject for the entire study period and willingness to adhere to
protocol requirements.
Healthy male subjects, 18 through 45 years of age, subjects having weight at least
50Kg and the subject?s body mass index (BMI) must be within 18.5 ? 25.0 (Kg/m2)
(inclusive).
Subjects who have no evidence of underlying disease during screening medical
history and whose physical examination is performed within 21 days prior to
commencement of the study.
Subjects whose screening laboratory values are within normal limits or considered
by the Principal Investigator/Sub-Investigator to be of no clinical significance.
Subjects in whom it is possible to perform the dosing technique properly after evaluation by using a placebo nasal spray bottle.
Informed consent form given in written form.
History or presence of significant:
Difficulty in taking an intranasal spray.
Ear-Nose-Throat disease, Cardiovascular, pulmonary, hepatic, renal, hematological,
gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological
or psychiatric disease.
Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational
drug within past one year.
Smoking (³ 10 cigarettes/day) or consumption of tobacco products ( 4 chews/day).
Hisory of difficulty in coming for follow up.
Clinically significant illness within 4 weeks before the start of the study
Subjects who have been on an abnormal diet (for whatever the reason) during the four
weeks preceding the study
Positive result to HIV, HBsAg, HCV, or VDRL/RPR.
Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates,
Gresiofulvine etc.) in the previous 30 days before day 1 of this study.
Abnormal 12 lead ECG, chest X-ray.
Donation of 350 ml or more of blood in the previous 90 days before day 1 of this study.
Participation in another clinical study within the preceding 90 days of study starts.
Subjects who have:
Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor
deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the clinical
investigator.
Pulse rate below 60/min. or above 100/min.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of treatment emergent adverse events (TEAE) from baseline to end-of study <br/ ><br>· Clinically significant change from baseline to end-of-study in: <br/ ><br>i. Laboratory parameters (Hematology, biochemistry, urinalysis) <br/ ><br>ii. Vital signs (Seated blood pressure, pulse, temperature) <br/ ><br>iii. Physical examination (Systemic examination, anterior rhinoscopy) <br/ ><br>iv. ECG intervalsTimepoint: Proportion of treatment emergent adverse events (TEAE) from baseline to end-of study <br/ ><br>· Clinically significant change from baseline to end-of-study in: <br/ ><br>i. Laboratory parameters (Hematology, biochemistry, urinalysis) <br/ ><br>ii. Vital signs (Seated blood pressure, pulse, temperature) <br/ ><br>iii. Physical examination (Systemic examination, anterior rhinoscopy) <br/ ><br>iv. ECG intervals
- Secondary Outcome Measures
Name Time Method Cmax , Cmin, Cav, AUC0-tau , Tmax , t½ ,% Fluctuation & Kel of S0597 and Fluticasone <br/ ><br>propionate (FP).Timepoint: Cmax , Cmin, Cav, AUC0-tau , Tmax , t½ ,% Fluctuation & Kel of S0597 and Fluticasone <br/ ><br>propionate (FP).