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Houston, TX, United States

Stavros F.,Encysive Pharmaceuticals | Kramer W.G.,Kramer Consulting LLC | Wilkins M.R.,Imperial College London
British Journal of Clinical Pharmacology | Year: 2010

Aims This study evaluated the effects of sitaxentan on the pharmacodynamic [systemic blood pressure (BP)] and pharmacokinetic (PK) parameters of sildenafil in healthy volunteers. Methods Healthy subjects (18-60 years, n = 24) were randomized into two sequence groups. Group 1 received sitaxentan sodium 100 mg daily (7 days), followed by placebo (7 days). Group 2 received placebo (7 days), followed by sitaxentan sodium 100 mg (7 days). On day 7 of each treatment period, participants received sildenafil 100 mg. PK parameters and BP were analysed on day 7 in each treatment period. Results Sildenafil exposure was slightly higher [AUC ∞ geometric mean ratio (GMR), 128%] when co-administered with sitaxentan 100 mg vs. placebo, demonstrating a weak, but statistically significant interaction (90% confidence interval 115.5%, 141.2%). The mean maximum positive (E max+) and maximum negative (E max-) changes from baseline in both systolic and diastolic BP were comparable for sitaxentan and placebo (range 4.8-7.3 mmHg) with three of four geometric mean ratios falling within the equivalence window, suggesting that the drug interaction was not clinically significant. Adverse events were similar between sitaxentan 100 mg (39%) and placebo (30%). No deaths or serious adverse events occurred during the study. Conclusion The dose of sildenafil does not need to be adjusted when co-administered with sitaxentan. © 2010 The British Pharmacological Society. Source


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 100.00K | Year: 2004

DESCRIPTION (provided by applicant): Rheumatoid Arthritis (RA) is a degenerative chronic inflammatory disease involving multiple peripheral joints. Diagnosis is associated with a poor prognosis, including decreased life expectancy. It is thought to affe


Trademark
Encysive Pharmaceuticals | Date: 2007-10-18

Pharmaceutical preparation for the treatment of heart failure, essential hypertension, prostate cancer, pulmonary hypertension, subarachnoid hemorrhage, asthma, psoriasis and organ reperfusion injury.


Trademark
Encysive Pharmaceuticals | Date: 2005-12-14

Pharmaceutical preparation for the treatment of heart failure, essential hypertension, prostate cancer, pulmonary hypertension, subarachnoid hemorrhage, asthma, psoriasis and organ reperfusion injury.


Encysive Pharmaceuticals | Entity website

Principles The Pfizer Board understands and acts on the fundamental principle that good corporate governance is critical to organizational success and the protection of shareholder value. In 1994, the Pfizer Board took the unprecedented step of creating a corporate governance committee of the Board ...

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