title: Pharmacokinetic Study of a Diclofenac Sodium Capsule Filled with Enteric-coated Pellets in Healthy Chinese Volunteers by Liquid Chromatography-electrospray Ionization-tandem Mass Spectrometry.
abstract: The pharmacokinetic study of a diclofenac sodium capsule filled with enteric-coated pellets (abbreviated as CAPSULE) in healthy Chinese subjects was evaluated using liquid chromatography-electrospray ionization-tandem mass spectrometry with simple sample preparation. In a cross-over study, 12 healthy male volunteers were given 50 mg CAPSULE and diclofenac sodium enteric-coated tablet (abbreviated as TABLET, used as a control dosage form) at fasting. The Cmax, AUC0-t, and Tmax of CAPSULE were 1.01±0.52 μg/mL, 1.54±0.18 μg·h/mL, and 1.50±1.31 h, respectively. When compared with TABLET, the pharmacokinetic study showed that although this CAPSULE exhibited similar AUC (only 10% lower), it presented lower maximum plasma concentration, faster absorption and shorter time to reach maximum concentration. When compared with the previous study in Germany, obvious variations on Tmax were found in Chinese subjects taking CAPSULE, but not TABLET. The results indicated that individual difference should be paid attention when prescribing CAPSULE to Chinese patients.
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
authors.forename: J-Y
authors.initials: JY
authors.lastname: Ma
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
authors.forename: M
authors.initials: M
authors.lastname: Liu
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
authors.forename: M
authors.initials: M
authors.lastname: Yang
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
authors.forename: H
authors.initials: H
authors.lastname: Zhao
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Tong
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
authors.forename: M
authors.initials: M
authors.lastname: Deng
authors.affiliation: Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.
authors.forename: H
authors.initials: H
authors.lastname: Liu
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D002214:Capsules; D002681:China; D002853:Chromatography, Liquid; D018592:Cross-Over Studies; D004008:Diclofenac / Q000008:administration & dosage / Q000493:pharmacokinetics*; D064368:Healthy Volunteers; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D021241:Spectrometry, Mass, Electrospray Ionization; D013608:Tablets, Enteric-Coated; D053719:Tandem Mass Spectrometry; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002214:Capsules; D013608:Tablets, Enteric-Coated; D004008:Diclofenac