Pharmacokinetics of Sildenafil Orally Soluble Film
- Conditions
- Not Applicable
- Registration Number
- KCT0000734
- Lead Sponsor
- CTC Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 50
1. Healthy male subjects between the ages of 20 and 55 years
2. Ideal Body Weight(IBW) of +-20%; and a total body weight >= 50 kg
3. An informed consent document signed and dated by the subject.
1. Evidence or a history of clinically significant hepatic, pancreas, renal, neurological, pulmonary, endocrine, hematological, psychiatric, cardiovascular, eye, genitourinary disease
2. Any disease or history possibly affecting drug absorption (e.g. chohn's disease, gastrectomy).
3. Any condition possibly affecting drug absorption (stomatitis, glottitis)
4. sildenafil-associated allergy history
5. systolic blood pressure (SBP) = 150 mmHg or =100 mmHg or diastolic blood pressure (DBP) = 95 mmHg or = 65 mmHg
6. received any prescription medication or herbal medicines within 3 weeks or any over-the-counter medication within 10 days before the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax;AUClast
- Secondary Outcome Measures
Name Time Method AUCinf