Pharmacokinetics and bioequivalence evaluation of 2 levosulpiride preparations after a single oral dose in healthy male Korean volunteers

Hy, Cho; Moon, JD; Yb, Lee

doi:10.5414/cpp42074

Cited by 3 publications

(4 citation statements)

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“…The bioequivalent parameters almost overlapped between test and reference. In previous reports, absorption of levosulpiride after oral administration was rapid with 46-81 ng/mL of C max , 3.1-3.5 h of T max and 8.7-10.9 h of half-life (T 1/2 ) in fasting conditions (Cho et al, 2004;Jin et al, 2004). Our experimental results agreed well with those studies.…”

Section: Clinical Application In Healthy Subjectssupporting

confidence: 82%

“…Pharmacokinetics of levosupiride have been reported in healthy volunteers (Wiesel et al, 1980;Bressolle et al, 1992;Cho et al, 2004;Jin et al, 2004). Because of incomplete absorption from the gastrointestinal tract, estimated bioavailability of orally administered levosulpiride was demonstrated to be approximately 30% with marked interindividual differences.…”

Section: Introductionmentioning

confidence: 99%

“…GC/MS techniques were reported early in the development of sulpiride and presented a low sensitivity of 50 ng/mL with time-consuming pre-column derivatization (Frigerio and Pantarotto, 1977). Several HPLC methods coupled with fluorescence detection (Tokunaga et al, 1997;Cho and Lee, 2003;Cho et al, 2004;Jin et al, 2004) and ultraviolet detection (UVD) (Bressolle and Bres, 1985;Koo et al, 2006) were developed. However, these methods possess disadvantages such as long analytical run times or back-extraction procedures for clear separation of levosulpiride, even though they presented sufficiently low lower limits of quantitation (LLOQs) of 0.25-10 ng/mL.…”

Section: Introductionmentioning

confidence: 99%

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Rapid quantification of levosulpiride in human plasma using RP‐HPLC‐MS/MS for pharmacokinetic and bioequivalence study

Park¹,

Park²,

Rhim³

et al. 2009

Biomedical Chromatography

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A rapid and validated method for analysis of levosulpiride in human plasma using liquid chromatography coupled to tandem mass spectrometry was developed. Levosulpiride and tiapride (IS, internal standard) were extracted from alkalized plasma samples with ethylacetate and separation by RP-HPLC. Detection was performed by positive ion electrospray ionization in multiple-reaction monitoring mode, monitoring the transitions m/z 342.1 --> m/z 112.2 and m/z 329.1 --> m/z 213.2, for quantification of levosulpiride and IS, respectively. The standard calibration curves showed good linearity within the range of 2-200 ng/mL (r(2) > or = 0.9990). The lower limit of quantitation was 2 ng/mL. The retention times of levosulpiride (0.63 min) and IS (0.66 min) presented a significant time saving benefit of the proposed method. No significant metabolic compounds were found to interfere with the analysis. This method offered good precision and accuracy and was successfully applied for the pharmacokinetic and bioequivalence study of a 25 mg of levosulpiride tablet in 24 healthy Korean volunteers.

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Section: Clinical Application In Healthy Subjectssupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Rapid quantification of levosulpiride in human plasma using RP‐HPLC‐MS/MS for pharmacokinetic and bioequivalence study

Park¹,

Park²,

Rhim³

et al. 2009

Biomedical Chromatography

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“…Levosulpiride was absorbed rapidly, with a T max less than 0.5 h after im administration, consistent with the results from a previous study in Caucasians 10 , 15 . The AUC after im injections of levosulpiride in our study were much larger than those after oral administration of the same levosulpiride dose in Korean volunteers 16 , 22 , 23 , but similar to values after im administration of sulpiride in Caucasians 10 , 14 . The V z / F was 146±33 L (25 mg dose study) and 143±28 L (50 mg dose study), suggesting that levosulpiride was widely distributed all over the body or distributed largely in a specific tissue.…”

Section: Resultssupporting

confidence: 70%

Pharmacokinetics of levosulpiride after single and multiple intramuscular administrations in healthy Chinese volunteers

Gong

Agbokponto

Yang

et al. 2014

Acta Pharmaceutica Sinica B

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The main purpose of this study was to evaluate the pharmacokinetics of levosulpiride in humans after single and multiple intramuscular injections. Six males and six females received single dose of either 25 mg or 50 mg levosulpiride, or multiple doses of 25 mg every 12 h for 5 consecutive days. In the single 25 mg study, the mean peak plasma concentration (Cmax) was 441 ng/mL, the mean area under the concentration–time curve from 0 to 36 h (AUC0–36) was 1724 ng h/mL, and the mean elimination half-life (t1/2) was 7.0 h. In the single 50 mg study, the mean Cmax was 823 ng/mL, the mean AUC0–36 was 3748 ng·h/mL, and the mean t1/2 was 6.8 h. After multiple doses of 25 mg levosulpiride, the average plasma concentration (Cav) was 136 ng/mL, the fluctuation index (DF) was 3.60, and the accumulation ratio (R) was 1.2. Levosulpiride injections appeared to be well tolerated by the subjects, and can be used for successive administration.

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Bioequivalence of a New Oral Levosulpiride Formulation Compared With a Standard One in Healthy Volunteers

Gregori

Cipollina

Silvestri

et al. 2017

Therapeutic Drug Monitoring

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Pharmacokinetics and bioequivalence evaluation of 2 levosulpiride preparations after a single oral dose in healthy male Korean volunteers

Cited by 3 publications

References 0 publications

Rapid quantification of levosulpiride in human plasma using RP‐HPLC‐MS/MS for pharmacokinetic and bioequivalence study

Rapid quantification of levosulpiride in human plasma using RP‐HPLC‐MS/MS for pharmacokinetic and bioequivalence study

Pharmacokinetics of levosulpiride after single and multiple intramuscular administrations in healthy Chinese volunteers

Bioequivalence of a New Oral Levosulpiride Formulation Compared With a Standard One in Healthy Volunteers

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