[Comparative studies on biologic availability and pharmacokinetics of bromazepam in tablets]. 1983

O von Stetten, and K D Rehm, and E Fenzl, and M F Barkworth, and K I Johnson

Ten male volunteers participated in a randomized crossover trial to compare the bioavailability of bromazepam (7-bromo-1,3-dihydro-5-(2-pyridyl)-2H-1,4-benzodiazepin-2-one) from two different preparations (Normoc, the test preparation, and a commercially available standard preparation). A single dose of 6 mg bromazepam was given. There was no difference in the USP XX rotating basket dissolution test between both preparations. The pharmacokinetic parameters elimination half-life, maximum plasma concentration and area under the curve were not significantly different. With the test preparation, however, smaller interindividual differences were seen. Only the time to peak plasma concentration showed a statistically significant difference. The test preparation yielded a flatter and smoother plasma bromazepam concentration curve compared with the standard preparation. This seems favourable in the case of subchronic dosing with regard to side effects, e.g. sedation.

UI MeSH Term Description Entries
D007700 Kinetics The rate dynamics in chemical or physical systems.
D008297 Male Males
D001960 Bromazepam One of the BENZODIAZEPINES that is used in the treatment of ANXIETY DISORDERS. Anxyrex,Apo-Bromazepam,BromaLich,Bromaz 1A Pharma,Bromazanil,Bromazep Von Ct,Bromazepam AL,Bromazepam Beta,Bromazepam Heumann,Bromazepam-Neuraxpharm,Bromazepam-Ratiopharm,Durazanil,Gen-Bromazepam,Lexatin,Lexomil,Lexotan,Lexotanil,Ro 5-3350,Apo Bromazepam,Beta, Bromazepam,Bromazepam Neuraxpharm,Bromazepam Ratiopharm,Gen Bromazepam,Ro 53350,Von Ct, Bromazep
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D001682 Biological Availability The extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Availability Equivalency,Bioavailability,Physiologic Availability,Availability, Biologic,Availability, Biological,Availability, Physiologic,Biologic Availability,Availabilities, Biologic,Availabilities, Biological,Availabilities, Physiologic,Availability Equivalencies,Bioavailabilities,Biologic Availabilities,Biological Availabilities,Equivalencies, Availability,Equivalency, Availability,Physiologic Availabilities
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet
D014151 Anti-Anxiety Agents Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. Anti-Anxiety Agent,Anti-Anxiety Drug,Anxiolytic,Anxiolytic Agent,Anxiolytic Agents,Tranquilizing Agents, Minor,Anti-Anxiety Drugs,Anti-Anxiety Effect,Anti-Anxiety Effects,Antianxiety Effect,Antianxiety Effects,Anxiolytic Effect,Anxiolytic Effects,Anxiolytics,Tranquillizing Agents, Minor,Agent, Anti-Anxiety,Agent, Anxiolytic,Agents, Anti-Anxiety,Agents, Anxiolytic,Agents, Minor Tranquilizing,Agents, Minor Tranquillizing,Anti Anxiety Agent,Anti Anxiety Agents,Anti Anxiety Drug,Anti Anxiety Drugs,Anti Anxiety Effect,Anti Anxiety Effects,Drug, Anti-Anxiety,Drugs, Anti-Anxiety,Effect, Anti-Anxiety,Effect, Antianxiety,Effect, Anxiolytic,Effects, Anti-Anxiety,Effects, Antianxiety,Effects, Anxiolytic,Minor Tranquilizing Agents,Minor Tranquillizing Agents

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