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Phase I/II a Unit.
ERGOMED has had its own Phase I/IIa Unit since 2002, located within
the Department of Clinical Pharmacology at the large University
Clinical Hospital, Sveti Duh, in Zagreb, Croatia. This 12-bed unit
focuses on specific patient populations or works with healthy subjects
as appropriate and is capable of performing PK, dose-finding, safety
and other Phase I and early Phase II studies. It operates to the
highest quality standards and has successfully undergone several
independent audits.
The unit is capable of performing single and multiple dose PK
studies (including first administration to humans), food and drug
PK interactions, as well as bioequivalence and bioavailability
studies. The experienced staff and the infrastructure, embedded
within a large general hospital, make it an ideal setting for special
Phase IIa proof- of-concept studies.
Phase I/IIa Unit with access to:
- Healthy subjects
- Special patient populations
• Renal-impaired patients
• Hepatic-impaired patients
• Oncology patients
• Neurology patients
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