None listed
Conditions
Interventions
Intervention1: S0597: steroid,800mcg to be administered as a nasal spray up to 14 days
Intervention2: S0597: Steroid, 1600mcg to be administered as a nasal spray up to 14 days
Intervention3: S0597: St
Sponsors
Atul Raut MD PhD
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of treatment emergent adverse events (TEAE) from baseline to end-of study · Clinically significant change from baseline to end-of-study in: i. Laboratory parameters (Hematology, biochemistry, urinalysis) ii. Vital signs (Seated blood pressure, pulse, temperature) iii. Physical examination (Systemic examination, anterior rhinoscopy) iv. ECG intervalsTimepoint: Proportion of treatment emergent adverse events (TEAE) from baseline to end-of study · Clinically significant change from baseline to end-of-study in: i. Laboratory parameters (Hematology, biochemistry, urinalysis) ii. Vital signs (Seated blood pressure, pulse, temperature) iii. Physical examination (Systemic examination, anterior rhinoscopy) iv. ECG intervals | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax , Cmin, Cav, AUC0-tau , Tmax , t½ ,% Fluctuation & Kel of S0597 and Fluticasone propionate (FP).Timepoint: Cmax , Cmin, Cav, AUC0-tau , Tmax , t½ ,% Fluctuation & Kel of S0597 and Fluticasone propionate (FP). | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed