Safety, tolerability and pharmacokinetics of trimebutine 3-thiocarbamoylbenzenesulfonate (GIC-1001) in a randomized phase I integrated design study: Single and multiple ascending doses and effect of food in healthy volunteers

Clinical Therapeutics

Volumn 36, Issue 11, 2014, Pages 1650-1664

  Paquette, Jean Michel ^a   Rufiange, Marianne ^a   Niculita, Mirela Iovu ^a   Massicotte, Julie ^a   Lefebvre, Marc ^a   Colin, Patrick ^b   Telmat, Ariles ^b   Ranger, Maxime ^b  

^a Algorithme Pharma Inc   (Canada)

^b INSTITUTE FOR RESEARCH IN IMMUNOLOGY AND CANCER   (Canada)

Author keywords

Colonoscopy; First in human; Gastroenterology; Phase I; Sedation free

Indexed keywords

AMINOTRANSFERASE; ANALGESIC AGENT; DIPHENHYDRAMINE; PLACEBO; TRIMEBUTINE 3 THIOCARBAMOYLBENZENESULFONATE; UNCLASSIFIED DRUG; BENZENESULFONIC ACID DERIVATIVE; TRIMEBUTINE 3-THIOCARBAMOYLBENZENESULFONATE;

ADULT; AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; BODY MASS; COHORT ANALYSIS; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG ERUPTION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; FEMALE; FOOD INTAKE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; LABORATORY TEST; LIMIT OF QUANTITATION; MALE; MAXIMUM PLASMA CONCENTRATION; MINIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PHYSICAL EXAMINATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; STEADY STATE; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; VISCERAL PAIN; VITAL SIGN; AGED; CLINICAL TRIAL; COLONOSCOPY; FOOD DRUG INTERACTION; LEAST SQUARE ANALYSIS; MIDDLE AGED; PAIN;

ADULT; AGED; ANALGESICS; AREA UNDER CURVE; BENZENESULFONATES; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; COLONOSCOPY; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; LEAST-SQUARES ANALYSIS; MALE; MIDDLE AGED; PAIN; TANDEM MASS SPECTROMETRY;

EID: 84911941759     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2014.08.005     Document Type: Article

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