Journal of Bioequivalence & Bioavailability

Suggestions for stage I of clinical trials of Diclocor

7^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 29-31, 2016 Atlanta, USA

Oleksii Popov and Sergiy Shebeko

National University of Pharmacy, Ukraine

Posters & Accepted Abstracts: J Bioequiv Availab

Abstract:

Medication Diclocor is the original capsulated pharmaceutical composition which contains classical, non-steroid and antiinflammatory drug diclofenac sodium and a lipoxygenase inhibiting bioflavonoid quercetin. Additionally, it possesses antioxidant, angioprotective, cardioprotective and other activity. The results of the conducted preclinical trials have proven that Diclocor obtains pronounced anti-inflammatory, analgesic, cardioprotective, and chondroprotective activity, which is higher than that of the known drugs like voltaren and quercetin. A prominent feature of this medication is a modifying influence of quercetin on pharmacological and toxicological properties of diclofenac sodium providing for a reduction of the effective dose of diclofenac sodium and, thus, for decrease in side effect incidence and rise of tolerability. It is possible that quercetin enhances bioavailability of diclofenac sodium leading to synergy in the form of potentiating or additive effect. Diclocor is recommended for phase I clinical trials and the suggested schemes are as follows: 1) For single dose tolerability study- 2 capsules (50 mg by diclofenac sodium) and 3 capsules (75 mg by diclofenac sodium); 2) for course dose tolerability study- 1 capsule 2 times a day (50 mg/day by diclofenac sodium) and 2 capsules 2 times a day (100 mg/day by diclofenac sodium). The optimal treatment course length is 7 days.

Biography :

Oleksii Popov is an aspirant of the Department of Clinical Pharmacology and Clinical Pharmacy of the National University of Pharmacy, Ukraine with a number of articles published in reputed international and Ukrainian scientific journals.

Email: oleksii.s.popov@gmail.com