title: Pharmacokinetics of single- and multiple-dose emtricitabine in healthy male Chinese volunteers.
abstract: Emtricitabine (FTC) is used for the treatment of HIV infection and pre-exposure chemoprophylaxis. It is often used in combination with tenofovir disoproxil fumarate (TDF). This study was designed to evaluate FTC pharmacokinetics in healthy male Chinese volunteers. Sixty subjects were recruited into this single-centre, randomised, open-label study and randomly received single (groups A, B and C) or multiple oral doses (once daily for 6 days; groups D, E and F) of 200-mg FTC capsules alone (A and D), or combined with 300-mg TDF tablets (B and E), or 200 mg of FTC plus 300 mg of TDF with a high-fat diet (C and F), respectively. FTC was well-tolerated in all groups. After a single dose, there were no differences in the mean AUC0-∞ values; however, there were significant differences in the mean Tmax values (1.05, 1.40 and 2.10 h for groups A, B and C, respectively; p < 0.05). In the multiple-dose study, our results were significantly different from published t1/2 values following single-dose FTC.
authors.affiliation: Department of Pharmacology,School of Public Health and Management, Chongqing Medical University, Chongqing, PR China.
authors.forename: Wen-Li
authors.initials: WL
authors.lastname: Han
authors.forename: Jing-Chuan
authors.initials: JC
authors.lastname: Shang
authors.forename: Bo
authors.initials: B
authors.lastname: Yan
authors.forename: Rui
authors.initials: R
authors.lastname: Tan
authors.forename: Wen-Xiang
authors.initials: WX
authors.lastname: Huang
authors.forename: Xiao-Ni
authors.initials: XN
authors.lastname: Zhong
authors.forename: Jun-Qing
authors.initials: JQ
authors.lastname: Yang
authors.forename: Ai-Long
authors.initials: AL
authors.lastname: Huang
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D059305:Diet, High-Fat; D004334:Drug Administration Schedule; D000068679:Emtricitabine; D018565:Food-Drug Interactions; D006207:Half-Life; D006801:Humans; D008297:Male; D010757:Phosphorous Acids / Q000008:administration & dosage / Q000494:pharmacology*; D055815:Young Adult
chemical_list: C574165:9-(2-((bis(pivaloyloxymethoxy)phosphinoyl)methoxy)propyl)adenine; D019380:Anti-HIV Agents; D010757:Phosphorous Acids; D003841:Deoxycytidine; D000068679:Emtricitabine; D000225:Adenine