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1、ORIGINALRESEARCHpublished:20April2017doi:10.3389/fphar.2017.00212PharmacokineticPropertiesofThreeFormsofVaginalProgesteroneAdministeredinEitherSingleOrMultipleDoseRegimeninHealthyPost-menopausalChineseWomenGuolanWu1†,JunchunChen2†,XingjiangHu1,HuiliZhou1,JianLiu1,DuoLv1,
2、LihuaWu1andJianzhongShentu1*1ResearchCenterforClinicalPharmacy,StateKeyLaboratoryforDiagnosisandTreatmentofInfectiousDisease,FirstAffiliatedHospital,CollegeofMedicine,ZhejiangUniversity,Hangzhou,China,2DepartmentofEducation,FirstAffiliatedHospital,CollegeofMedicine,Zhejian
3、gUniversity,Hangzhou,ChinaObjective:AgenericvaginalprogesteronegelhasrecentlybeendevelopedinChina.Editedby:LittleisknownaboutitspharmacokineticpropertiesinChinesesubjects.ThepurposeJudithAnnSmith,UniversityofTexasHealthScienceofourstudywastoinvestigatethepharmacokinetics
4、ofthreeformsofvaginalCenteratHouston,USAprogesteronegel(testformulationsat4and8%strengthvs.areferenceformulation:Reviewedby:Crinone8%)inChinesehealthypost-menopausalwomen.JonathanPaulFaro,HospitalCorporationofAmerica,USAMethods:Thisstudyconsistedoftwopartsstudy.Thepart1s
5、tudywasasingle-center,DanielJ.Licht,open-label,3-periodstudy.Twelvehealthypost-menopausalwomenweretoevaluateChildren’sHospitalofPhiladelphia,USAthesafetyandpharmacokineticsof45mgvaginalprogesteronegel(Test4%)following*Correspondence:singledoseandmultipledosesadministered
6、onceeveryotherday(q.o.d.)forsixtimesJianzhongShentuoroncedaily(q.d.)for6days.Thepart2studywasarandomized,open-label,3-stagestjz@zju.edu.cncrossoverstudy.Twelvepost-menopausalwomenreceived90mgvaginalprogesterone†Theseauthorshavecontributedgel(Test8%)or90mgCrinone(Referenc
7、e8%)followingsingledoseandmultipledosesequallytothiswork.(q.o.d.orq.d.).Plasmaconcentrationsofprogesteroneweremeasuredupto72hSpecialtysection:byusingavalidatedliquidchromatographytandem-massspectrometrymethod.TheThisarticlewassubmittedtoprimarypharmacokineticparameters,m
8、aximumplasmaconcentration(Cmax)andareaObstetricandPediatricPharmacology,undertheplasmaconcentration–tim
