PMID- 20110015
OWN - NLM
STAT- MEDLINE
DCOM- 20100409
LR  - 20131121
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 31
IP  - 11
DP  - 2009 Nov
TI  - Relative bioavailability of generic and branded 250-mg and 500-mg oral 
      chlorphenesin carbamate tablets in healthy Korean volunteers: a single-dose, 
      randomized-sequence, open-label, two-period crossover trial.
PG  - 2735-43
LID - 10.1016/j.clinthera.2009.11.036 [doi]
AB  - BACKGROUND: Chlorphenesin carbamate is a skeletal muscle relaxant approved in 
      Korea for use in the treatment of pain and discomfort related to skeletal muscle 
      trauma and inflammation. OBJECTIVE: The aim of this study was to assess the 
      bioequivalence of a generic formulation of chlorphenesin carbamate at doses of 
      250 and 500 mg and 2 branded formulations of the same doses in healthy Korean 
      adults. METHODS: This single-dose, randomized-sequence, open-label, 2-period 
      crossover study was conducted in healthy Korean male and female volunteers. 
      Subjects were assigned to receive, in a randomized sequence, a single dose of the 
      generic (test) and branded (reference) formulations of chlorphenesin carbamate at 
      a dose of 250 or 500 mg. Blood samples were drawn at 0, 0.33, 0.67, 1, 1.5, 2, 3, 
      4, 6, 9, 12, and 15 hours after administration. Pharmacokinetic properties 
      (C(max), T(max), AUC(0-t) AUC(0-infinity), t(1/2), and ke) were determined using 
      HPLC. The formulations were to be considered bioequivalent if the 90% CIs of the 
      treatment ratios of the geometric means of C(max) and AUC(0-t) were within a 
      predetermined range of log 0.80 to log 1.25 based on regulatory criteria. 
      Tolerability was assessed by monitoring for adverse events (AEs) on physical 
      examination and/or e-mail and personal interview at the beginning and end of each 
      study period. RESULTS: Twenty-eight subjects (22 men, 6 women) received 
      chlorphenesin carbamate at the 250-mg dose, and 24 male subjects received the 
      500-mg dose. The mean (SD) ages of the subjects were 24.0 (2.6) and 24.0 (1.9) 
      years in the 250- and 500-mg groups, respectively. No significant differences 
      were found between the test and reference formulations (90% CIs: C(max), 
      1.0048-1.1153 with the 250-mg dose and 0.9630-1.1189 with the 500-mg dose; 
      AUC(0-t), 0.9882-1.0546 and 0.9842-1.0578, respectively). No clinically 
      significant AEs (upper gastric pain, abdominal bloating, pyrexia, edema, nausea, 
      heartburn, constipation, headache, dizziness, drowsiness, or fatigue) were 
      reported throughout the study. CONCLUSION: In this single-dose study in these 
      healthy Korean subjects, the generic and branded formulations of chlorphenesin 
      carbamate 250 and 500 mg met the regulatory criteria for bioequivalence. All 
      formulations were well tolerated.
CI  - Copyright 2009 Excerpta Medica Inc. All rights reserved.
FAU - Yu, Ji-young
AU  - Yu JY
AD  - Division of Bioequivalence, Korea Drug Test Laboratory, Seoul, Republic of Korea.
FAU - Song, Hyun Ho
AU  - Song HH
FAU - Kim, Bo Gyeom
AU  - Kim BG
FAU - Park, Hyeon Ju
AU  - Park HJ
FAU - Choi, Kwang Sik
AU  - Choi KS
FAU - Kwon, Young Ee
AU  - Kwon YE
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Muscle Relaxants, Central)
RN  - 0 (Tablets)
RN  - 57U5YI11WP (chlorphenesin carbamate)
RN  - I670DAL4SZ (Chlorphenesin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Area Under Curve
MH  - Biological Availability
MH  - Chemistry, Pharmaceutical
MH  - Chlorphenesin/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacokinetics
MH  - Chromatography, High Pressure Liquid
MH  - Cross-Over Studies
MH  - Female
MH  - Half-Life
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscle Relaxants, Central/*administration & dosage/adverse 
      effects/*pharmacokinetics
MH  - Reproducibility of Results
MH  - Tablets
MH  - Therapeutic Equivalency
MH  - Young Adult
EDAT- 2010/01/30 06:00
MHDA- 2010/04/10 06:00
CRDT- 2010/01/30 06:00
PHST- 2009/08/31 00:00 [accepted]
PHST- 2010/01/30 06:00 [entrez]
PHST- 2010/01/30 06:00 [pubmed]
PHST- 2010/04/10 06:00 [medline]
AID - S0149-2918(09)00436-6 [pii]
AID - 10.1016/j.clinthera.2009.11.036 [doi]
PST - ppublish
SO  - Clin Ther. 2009 Nov;31(11):2735-43. doi: 10.1016/j.clinthera.2009.11.036.