THE POSSIBILITY FOR AVOIDANCE OF MUTUAL PHARMACOKINETIC INTERACTION BETWEEN SILDENAFIL AND BOSENTAN, STAGGERING ADMINISTRATION TIMING OF THE TWO DRUGS
Phase 4
Completed
- Conditions
- Pulmonary Hypertension
- Registration Number
- JPRN-UMIN000002566
- Lead Sponsor
- Hamamatsu University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1 Patients who entail obvious adverse side-effects of either bosentan or sildenafil. 2 Patients who hardly continue taking bosentan or sildenafil for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma cancentration of sildenafil and its primary metabolite N-desmethylsildenafil of the following blood samples; before dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h post dose of the first sildenafil on the day.
- Secondary Outcome Measures
Name Time Method # Plasma concentration of Bosentan of the same points above. # Blood pressure of before dose, 1 and 3 h post dose of the first sildenafil on the day.