Authorization obtained for phase I clinical study in new drug for treatment and relief of hemorrhoids

The investigational drug is a gel for rectal and topical use with a unique mechanism of action that has not been used before in any medicinal drugs currently available on the market.

Due to the use of nanotechnologies the developers significantly improved physical and chemical properties of active substances of the drug. In addition, a new combinatorial treatment solution has been found. For the first time two active substances (nifedipine and lidocaine) were combined to provide both therapeutic and analgesic effects. The investigational drug is a non-greasy gel which makes it easy to use and ensures long storage life.

This study aims to evaluate the safety, tolerability and pharmacokinetics of the drug provided as a single dose therapy in healthy volunteers.

This is a full-service clinical project in which OCT will provide full project management services from trial monitoring to drug registration. OCT has already successfully completed a number of pre-clinical studies for this project. OCT has extensive experience in phase I clinical trials in a variety of therapeutic areas.