KCT0000419Recruiting未知
A Randomized, Opne-label, Single dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess the Pharmacokinetic Charateristics of Sildenafil citrate Chewable Tablets Compared with Sildenafil citrate Film-coated Tablets under Fasted Conditions in Healthy Male Subjects
Korea United Pharm0 sites60 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 55(Year) (—)
- Sex
- Male
Inclusion Criteria
- •1. Healthy male volunteers between the ages of 20 and 55 years at screening
- •2. Subjects with a body weight within ± 20% of their ideal weight and over 55kg
- •3. Subjects have to be able to read, hear, and understand the detail of the study, and should decide to participate in the study volntarily and follow the study directions and provide written informed consent.
Exclusion Criteria
- •1. History of hypersentivity to sildenafil citrate
- •2. Administration of organic nitrates
- •3. Subject who has retinitis pigmentosa
- •4. Current use of other PDE5 inhibitors such as VIAGRA, CIALIS, LEVITRA,ZYDENA, MVIX, and so on
- •5. Visual field loss due to non-arterial anterial ischemic optic neuropathy
- •6. Subjects with systolic blood pressure = 100 mmHg or = 150 mmHg, or diastolic blood pressure = 50 mmHg or = 145 mmHg, or with pulse rate < 45 bpm or > 100 bpm
- •7. Subjects with AST or ALT count, the upper limit of reference range in excess of 1.25 times, or total bilirubin, the upper limit of reference range in excess of 1. 5 times
- •8. Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic, gastrointestinal, central nervous system, psychiatric, or malignant diseases
- •9. heavy drinker (more than 21 units/week) or heavy smoker (more than 20 cigarettes/day)
- •10. Use of any prescription drug, herbal medications within 14 days, or any over-the-counter medication within 7 days prior to scheduled study drug administration
- •11. Use of any other investigational drugs within 3 months prior to scheduled study drug administration
- •12. Donation of whole blood within 2 months or any blood products within 1 month, prior to scheduled study drug administration
- •13. Use of drugs which are P450 inducers or inhibitors (e.g. Phenobarbital) within 1 month prior to scheduled study drug administration
- •14. Current or previous abuse of drugs or alcohol
Investigators
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