| INVESTIGATOR'S
BROCHURE: summaries of the studies performed with IQB-9302
PEI
(Producto en Investigación): Documents submitted to the Agencia
Española del Medicamento)
DOCUMENTS
Full reports
from RCOs and Investigators (PDF format)
PHARMACOLOGY:
 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)
TOXICITY
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)
PHARMACOKINETICS
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
MUTAGENICITY
Ames
test (26 pages, 91 KB)
CHEMISTRY-GALENICS
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)
MISCELANEOUS
Expert
Report of Preclinical Studies. V.01 May 1999 (in Spanish, 21 pages,
186 KB)
CLINICAL TRIALS
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)
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