title: Pharmacokinetics and Safety of DW1029M, a Botanical Drug for the Treatment of Diabetic Nephropathy, Following Single Doses in Healthy Subjects.
abstract: DW1029M is a botanical extract of Morus albalinne root bark and Puerariae radix that is used for the treatment of diabetic nephropathy. This study evaluated the safety and pharmacokinetics of DW1029M following its administration in healthy Korean subjects. We conducted a randomized, open-label, single-dose, crossover phase 1 clinical study. During each period, subjects received 300, 600, or 1200 mg oral doses of DW1029M. Plasma concentrations of puerarin, daidzin, and daidzein were analyzed using a liquid chromatography-tandem mass spectrometry. Six healthy male subjects completed the study. The maximum concentration of the drug in the plasma (Cmax) and area under the plasma drug concentration-time curve to the last measurable concentration (AUClast) for puerarin, daidzin, and daidzein were assessed after oral administration of DW1029M. No serious adverse events or clinically or statistically significant adverse events associated with any of the drug levels were observed. The results of the measurement of vital signs, electrocardiogram, laboratory tests, and physical examinations indicated that no clinically significant changes occurred during this study. The DW1029M tablet was safe and well tolerated over a single dose range of 300-1200 mg. This pharmacokinetic study of a botanical drug may aid in the development of DW1029M.
authors.affiliation: Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.
authors.forename: Yunjeong
authors.initials: Y
authors.lastname: Kim
authors.affiliation: Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.
authors.forename: Ji-Young
authors.initials: JY
authors.lastname: Jeon
authors.affiliation: Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.
authors.forename: Eun-Young
authors.initials: EY
authors.lastname: Kim
authors.affiliation: Department of Pharmacology, College of Medicine, Chung-ang University, Seoul, Republic of Korea.|Dongwha Pharmaceuticals Project Team, Seoul, Republic of Korea.
authors.forename: Cheol-Hee
authors.initials: CH
authors.lastname: Lim
authors.affiliation: Dongwha Pharmaceuticals Project Team, Seoul, Republic of Korea.
authors.forename: Hwan Bong
authors.initials: HB
authors.lastname: Jang
authors.affiliation: Center for Clinical Pharmacology and Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Republic of Korea.|Department of Pharmacology, School of Medicine, Chonbuk National University, Jeonju, Republic of Korea.
authors.forename: Min-Gul
authors.initials: MG
authors.lastname: Kim
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D018592:Cross-Over Studies; D003928:Diabetic Nephropathies / Q000188:drug therapy; D004334:Drug Administration Schedule; D006207:Half-Life; D064368:Healthy Volunteers; D006801:Humans; D007529:Isoflavones / Q000097:blood*; D008297:Male; D008875:Middle Aged; D031625:Morus / Q000737:chemistry*; D010936:Plant Extracts / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D011897:Random Allocation; D055815:Young Adult
chemical_list: D007529:Isoflavones; D010936:Plant Extracts; C013908:daidzin; C004742:daidzein; C033607:puerarin
keywords: DW1029M; botanical drug; clinical trials; pharmacokinetics; safety