VANCOUVER, British Columbia, June 22, 2011 (GLOBE NEWSWIRE) -- Global Health Ventures Inc. (OTCBB:GHLV - News), a specialty pharmaceutical company with focus on sublingual drug delivery is pleased to announce that it has completed the clinical trials, a pharmacokinetics (PK) study in Europe under EMEA guideline and the final report has been obtained.
In the study, 12 subjects were given 25 mg sildenafil base from Pfizer, oral formulation known as Viagra(R) and another 12 subjects were given 25 mg sildenafil citrate (20.6 mg X-Excite). Blood was taken from each tested subject at 1, 15, 20, 30 and 45 minutes and then 1, 2, 3, 5, 8, and 12 hours. The plasma samples were analyzed for sildenafil concentration with a method that has a lower limit of quantification (LLOQ) of 2 ng/ml. The primary objective was the blood pharmacokinetic analysis, maximal drug concentration and time from administration to maximal concentration in plasma (Cmax and Tmax), as well as area under plasma time/concentration curve from 0 to 8 hours of sildenafil (AUC).
The results in summary, showed, X-Excite to appear in the blood significantly faster than Viagra(R), stay in the blood longer, and based on actual sildenafil drug used, have a greater AUC. Furthermore, none of the subjects which received X-Excite, dropped out of trials nor any complications were observed. The trials provided the expected and successful end point.
"We are very pleased with the completion of our European trials and now we are proceeding with the clinical trials in the United States under the FDA guideline. First step in the U.S. trial, is to produce the drug in an FDA approved GMP facility. We have already started the process of manufacturing of our drug for U.S. clinical trials," said Dr. Hassan Salari, Chairman and CEO of Global Health Ventures Inc.
About Sublingual Technology
The Company's sublingual formulation is designed to enhance drugs to be delivered to the body without the need for injection. This design enables the vast majority of pharmaceutical drugs to be rapidly absorbed through the mucosal membrane (tissues of the mouth) quickly and efficiently. This technology works well for drugs that need faster results and have major side effects associated with gastrointestinal and/or liver break down. It is scientifically accepted that sublingual drug delivery route is the fastest and most efficient way of drug delivery after direct injection.
About Global Health Ventures (GHLV.ob) is a specialty pharmaceutical company with expertise in drug delivery and formulation. The Company's lead therapeutic product is a male sexual enhancement drug that is delivered via sublingual route and is called X-Excite. In human studies, X-Excite has been shown to reach the blood stream rapidly, producing maximal effect and having less of the unwanted side effects associated with oral delivery route. The Company's second drug "Relax-B" is also under development in Canada for anxiety. And, the third drug will be an anti-migraine drug. The Company plans to use the same technology to deliver a vast number of other FDA approved and non-approved drugs that require faster delivery, or reduced hepatic and gastrointestinal side effects. These include stress, sleeping disorders, pain killers, anti-allergy medications, heart and lung medication, migraine and addiction replacement therapies.
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