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Bioequivalence of Two 6-Mercaptopurine Tablet Formulations in Healthy Fasting Chinese Volunteers. 2023

Yaping Deng, and Guohua Wang, and Guojun Jiang, and Dandan Song, and Xian Xu, and Dandan Zhao, and Guojun Tan, and Zijun Tan, and Jian Chen
Department of Clinical Pharmacology, Affiliated Xiaoshan Hospital, Hangzhou Normal University, Hangzhou, Zhejiang, China.

The supply of branded 6-mercaptopurine (6-MP) is limited in China, necessitating the local production and clinical evaluation of generic alternatives. We evaluated the in vivo bioequivalence (BE) of a new generic mercaptopurine tablet (50 mg) formulation by comparing peak plasma concentration and area under the concentration-time curve (AUC) with a branded 6-MP formulation as the reference in 36 healthy fasting Chinese adults. The in vivo BE was evaluated by the average BE test. The safety parameters of the test and reference formulations were also evaluated. The geometric mean ratios for AUC over the dosing interval and AUC from time zero to infinity were 104% and 104%, respectively, of the reference values, while the point estimate of the geometric mean ratio for peak plasma concentration was 104% of the reference value. The test and reference formulations in this study were both deemed safe as only 23 Grade 1 adverse events were observed in 13 of 36 subjects. The test and reference formulations of 6-MP tablets meet the regulatory criteria for BE in healthy fasting Chinese adults.

UI MeSH Term Description Entries
D005215 Fasting Abstaining from FOOD. Hunger Strike,Hunger Strikes,Strike, Hunger,Strikes, Hunger
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000095225 East Asian People East Asians,Eastern Asian People,Eastern Asians,Far East Asians,Chinese,Japanese,Koreans,Asian People, East,Asian People, Eastern,Asian, East,Asian, Eastern,Asian, Far East,East Asian,East Asian Peoples,Eastern Asian,Eastern Asian Peoples,Far East Asian,People, East Asian,People, Eastern Asian
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
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D014838 Volunteers Persons who donate their services. Voluntary Workers,Volunteer Personnel,Untrained Personnel,Volunteer Workers,Volunteerism,Personnel, Untrained,Personnel, Volunteer,Voluntary Worker,Volunteer,Volunteer Worker,Worker, Voluntary,Worker, Volunteer
D015122 Mercaptopurine An antimetabolite antineoplastic agent with immunosuppressant properties. It interferes with nucleic acid synthesis by inhibiting purine metabolism and is used, usually in combination with other drugs, in the treatment of or in remission maintenance programs for leukemia. 6-Mercaptopurine,1,7-Dihydro-6H-purine-6-thione,6-Mercaptopurine Monohydrate,6-Thiohypoxanthine,6-Thiopurine,6H-Purine-6-thione, 1,7-dihydro-,BW 57-323H,Leupurin,Mecaptopurine Anhydrous,Mercaptopurina Wellcome,Puri-Nethol,Purimethol,Purinethol,6 Mercaptopurine,6 Mercaptopurine Monohydrate,6 Thiohypoxanthine,6 Thiopurine,BW 57 323H,BW 57323H

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