title: Pharmacokinetics and safety profiles of novel diethylstilbestrol orally dissolving film in comparison with diethylstilbestrol capsules in healthy Chinese male subjects.
abstract: OBJECTIVE
  We compared the pharmacokinetic (PK) profiles of diethylstilbestrol orally dissolving film (DES ODF) and DES-capsule as well as assessing the safety, local tolerability, taste, and disintegration time of DES ODF.
  
  
  METHODS
  Twelve healthy male volunteers receiving a single administration of 2.0 mg of DES ODF or DES-capsule were included in the study. The tolerability, taste, and time to dissolution of DES ODF were assessed after dosing. Safety assessments included adverse events, hematology and biochemistry tests, urinalysis, vital signs, and electrocardiography.
  
  
  RESULTS
  The PK parameters of DES ODF were all greater than those of DEScapsule. The Cmax values were 5.64 ± 1.1 and 3.4 ± 1.93 ng/mL for DES ODF and DES-capsule, respectively. Assessment of bioequivalence was based on the 90% CIs of the treatment ratios of the log-transformed Cmax, AUC0-t, and AUC0-∞ (DES ODF to DES-capsule), with the mean values being 1.93 (141 - 264), 1.24 (98 - 156), and 1.59 (121 - 207), respectively, indicating that DES ODF had a significantly high bioavailability. The mean DES ODF disintegration time was 14 ± 5 minutes. DES ODF was well tolerated and no serious adverse events or clinically relevant changes were observed.
  
  
  CONCLUSIONS
  The DES ODF is well tolerated and better absorbed in comparison with DES-capsule.
authors.forename: Hong
authors.initials: H
authors.lastname: Zhang
authors.forename: Hong
authors.initials: H
authors.lastname: Chen
authors.forename: Xiao-Jiao
authors.initials: XJ
authors.lastname: Li
authors.forename: Qi
authors.initials: Q
authors.lastname: Zhang
authors.forename: Yan-Fu
authors.initials: YF
authors.lastname: Sun
authors.forename: Cheng-Jiao
authors.initials: CJ
authors.lastname: Liu
authors.forename: Li-Zhi
authors.initials: LZ
authors.lastname: Yang
authors.forename: Yan-Hua
authors.initials: YH
authors.lastname: Ding
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D002681:China; D018592:Cross-Over Studies; D004054:Diethylstilbestrol / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D004968:Estrogens, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D006207:Half-Life; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D012737:Sex Factors; D012995:Solubility; D013649:Taste; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D002214:Capsules; D004968:Estrogens, Non-Steroidal; D004054:Diethylstilbestrol