This section of the Project will be always under construction. Dossiers from RCOs, data from laboratories and investigators will be periodically posted. Summaries of incoming studies will be posted into Investigator's Brochure

Project Progress


INVESTIGATOR'S BROCHURE:  summaries of the studies performed with IQB-9302

PEI (Producto en Investigación): Documents submitted to the Agencia Española del Medicamento)

Full reports from RCOs and Investigators (PDF format)


Infiltration anesthesia in the guinea-pig(42 pages, 379 KB)
Surface anesthesia in the guinea-pig (40 pages, 377 KB)
Inhibition of sciatic nerve activity (rat) (54 pages, 1.335 KB)
Effects on isolated rat aorta (basal tone and precontracted with Epinephrine and KCl 35 mM) (11 pages, 184 KB)
Effect of IQB-9302 on voltage-dependent Ca2+ channels and neuronal nicotinic receptor ion channels (9 pages, 75 Kb)
Effect of IQB-9302 on a3b4 neuronal nicotinic receptors expressed in oocytes (11 pages, 79 Kb)
Comparative antinoceptive and motor effects of IQB-9302 and bupivacaine given epidurally to dogs (Report in spanish, 37 pages)
Effects of the enantiomers of a new local anesthetic, IQB-9302, on a human cardiac potassium channel (Kv1.5)(Final Report, 33 pages, 669 KB)(Worksheets, 19 pages, 244 kb)
Comparison of the  hemodynamic effects of intravenous administration of IQB-9302 and bupivacaine in anesthesized rats (Draft Report, 6 pages; tables: 18 pages; figures: 10 pages)


In vitro effects on ventricular cardiac muscles (22 pages,  313 KB)
Acute intravenous toxicity in rats (96 pages,  1712 Kb) 
Subacute intravenous toxicity in rats (Dose-range finding) (135 pages, 2.534 KB)
Subcutaneous acute toxicity in beagle dogs (32 pages, 815 KB) 
Intravenous acute toxicity in beagle dogs  (27 pages, 720 KB
Subacute intravenous toxicity in rats (vol I) (4 week + two recovery weeks)(226 pages). (Vol II)
Subacute intravenous toxicity in beagle dogs (4 weeks + one recovery week) (306 pages, 6.5 MB)
Compatibility with blood and haemolytic potential (22 pages, 568KB)


Validation of a HPLC assay for IQB-9302 concentrations in dog plasma (17 pages 990 KB)
Validation of HPLC assay of IQB-9302 in human plasma


Ames test (26 pages, 91 KB)


Physico Chemical Properties (21 pages, 176 KB) including Galenic Formulations
Monograph of IQB-9302.HCl , Monograph of IQB-9302.HCl injection and Annex
Drug Master File  (version V.1.0)
Master formulae of IQB-9302 and bupivacaine for clinical studies (in Spanish)

Expert Report of Preclinical Studies. V.01 May 1999 (in Spanish, 21 pages, 186 KB)


Tolerance and local anesthetic effects of increasing intradermal doses of IQB-9302 in healthy volunteers.

Doubleblind comparison of increasing intradermal doses of IQB-9302 and bupivacaine given to healthy volunteers.

Double-blind crossover comparison of the anesthetic effects IQB-9302 and bupivacaine at 0.25 and 0.50% concentrations in the ulnar nerve (Spanish version : 62 pages, 396 kb; annexes: 35 pages, 3.5 MB)