title: Pharmacokinetic comparisons of two acetyl-L-carnitine formulations in healthy Korean volunteers.
abstract: BACKGROUND
  Acetyl-L-carnitine (ALC) has demonstrated neuroprotective effects in several experiments and is widely prescribed to reduce cognitive impairment in Alzheimer's disease patients or manage neuropathic symptoms in diabetic patients.
  
  
  OBJECTIVE
  This study was designed to assess the pharmacokinetic (PK) bioequivalence between a new generic (test) formulation of ALC hydrochloride 590 mg and a branded (reference) formulation of ALC hydrochloride 590 mg in healthy Korean male volunteers.
  
  
  METHODS
  This was a randomizedsequence, single-dose, two-way crossover study. All subjects randomly received one formulation of the test or reference tablet and the other formulation with a 7-day washout period. Blood samples (7 mL) were collected immediately before dosing, and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours postdose. The plasma concentrations of ALC were analyzed using liquid chromatography tandem mass spectrometry. Tolerability was assessed throughout the study.
  
  
  RESULTS
  The PK profiles of both formulations showed similar rends. The mean (±SD) baseline (predose) concentration of ALC was 1.23±0.31 μg/mL and 1.09±0.30 μg/mL for the test and the reference formulations, respectively. The mean Cmax for the test and reference formulations were 1.74±0.43 μg/mL and 1.68±0.48 μg/mL, respectively. The mean AUClast of ALC was 12.96±1.89 μg×h/mL and 12.49±2.44 μg×h/mL for the test and reference formulations, respectively. The geometric mean ratios of test/reference (90% CI) were 1.050 (0.960-1.149) for Cmax and 1.048 (1.000-1.099) for AUClast. Both formulations were well tolerated in all treatment groups.
  
  
  CONCLUSIONS
  The test and the reference formulations of ALC were bioequivalent with regard to the PK parameters.
authors.forename: Sang-Min
authors.initials: SM
authors.lastname: Baek
authors.forename: Renhua
authors.initials: R
authors.lastname: Zheng
authors.forename: Eun-Jung
authors.initials: EJ
authors.lastname: Seo
authors.forename: Dae-Yeon
authors.initials: DY
authors.lastname: Hwang
authors.forename: Bo-Hyung
authors.initials: BH
authors.lastname: Kim
mesh_terms: D000108:Acetylcarnitine / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D044466:Asian People; D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid; D018592:Cross-Over Studies; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics*; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D056910:Republic of Korea; D013607:Tablets; D053719:Tandem Mass Spectrometry; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D016568:Drugs, Generic; D018696:Neuroprotective Agents; D013607:Tablets; D000108:Acetylcarnitine