Study on bioequivalence of domestic methylprednisolone tablets

Z. Zhu; Q. Fu; P. Wang; X. W. Xu; D. K. Li; D. H. Huang

Study on bioequivalence of domestic methylprednisolone tablets

Z. Zhu, Q. Fu, P. Wang, X. W. Xu, D. K. Li, D. H. Huang

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

OBJECTIVE: To study the bioequivalence of methylprednisolone (MP) tablets in healthy volunteers. METHOD: A rapid and sensitive RP-HPLC assay was modified for the determination of the drug levels in plasma. In a randomized two-way crossover design, 40 mg single dose po domestic (B) and imported (A, Medrol™) MP tablets, respectively, were given to 18 male healthy volunteers. The parameters were estimated by non-compartment model with a statistic analysis of ANOVA and two one-side t-test. RESULTS: The t_max, c_max, t_1/2 and AUC_0-∞ of tablet-B and-A were (1.9 ± 0.5) h and (2.1 ± 0.5) h, (597.6 ± 119.8) ng·mL^-1 and (572.6 ± 121.7) ng·mL^-1, (2.2 ± 0.4) h and (2.3 ± 0.4) h, (2528.4 ± 558.8) h·ng·mL^-1 and (2571.2 ± 647.4) h·ng·mL^-1, respectively. The mean relative bioavailability of the tablet-B vs A was 99.62%. There was no significant difference between the two products. CONCLUSION: The results suggested that these two products were bioequivalent.

Original language	English
Pages (from-to)	261-264
Number of pages	4
Journal	Chinese Pharmaceutical Journal
Volume	36
Issue number	4
State	Published - 2001
Externally published	Yes

Keywords

Bioequivalence
HPLC
Methylprednisolone

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title = "Study on bioequivalence of domestic methylprednisolone tablets",

abstract = "OBJECTIVE: To study the bioequivalence of methylprednisolone (MP) tablets in healthy volunteers. METHOD: A rapid and sensitive RP-HPLC assay was modified for the determination of the drug levels in plasma. In a randomized two-way crossover design, 40 mg single dose po domestic (B) and imported (A, Medrol{\texttrademark}) MP tablets, respectively, were given to 18 male healthy volunteers. The parameters were estimated by non-compartment model with a statistic analysis of ANOVA and two one-side t-test. RESULTS: The tmax, cmax, t1/2 and AUC0-∞ of tablet-B and-A were (1.9 ± 0.5) h and (2.1 ± 0.5) h, (597.6 ± 119.8) ng·mL-1 and (572.6 ± 121.7) ng·mL-1, (2.2 ± 0.4) h and (2.3 ± 0.4) h, (2528.4 ± 558.8) h·ng·mL-1 and (2571.2 ± 647.4) h·ng·mL-1, respectively. The mean relative bioavailability of the tablet-B vs A was 99.62%. There was no significant difference between the two products. CONCLUSION: The results suggested that these two products were bioequivalent.",

keywords = "Bioequivalence, HPLC, Methylprednisolone",

author = "Z. Zhu and Q. Fu and P. Wang and Xu, {X. W.} and Li, {D. K.} and Huang, {D. H.}",

year = "2001",

language = "English",

volume = "36",

pages = "261--264",

journal = "Chinese Pharmaceutical Journal",

issn = "1001-2494",

publisher = "Chinese Pharmaceutical Association",

number = "4",

}

TY - JOUR

T1 - Study on bioequivalence of domestic methylprednisolone tablets

AU - Zhu, Z.

AU - Fu, Q.

AU - Wang, P.

AU - Xu, X. W.

AU - Li, D. K.

AU - Huang, D. H.

PY - 2001

Y1 - 2001

N2 - OBJECTIVE: To study the bioequivalence of methylprednisolone (MP) tablets in healthy volunteers. METHOD: A rapid and sensitive RP-HPLC assay was modified for the determination of the drug levels in plasma. In a randomized two-way crossover design, 40 mg single dose po domestic (B) and imported (A, Medrol™) MP tablets, respectively, were given to 18 male healthy volunteers. The parameters were estimated by non-compartment model with a statistic analysis of ANOVA and two one-side t-test. RESULTS: The tmax, cmax, t1/2 and AUC0-∞ of tablet-B and-A were (1.9 ± 0.5) h and (2.1 ± 0.5) h, (597.6 ± 119.8) ng·mL-1 and (572.6 ± 121.7) ng·mL-1, (2.2 ± 0.4) h and (2.3 ± 0.4) h, (2528.4 ± 558.8) h·ng·mL-1 and (2571.2 ± 647.4) h·ng·mL-1, respectively. The mean relative bioavailability of the tablet-B vs A was 99.62%. There was no significant difference between the two products. CONCLUSION: The results suggested that these two products were bioequivalent.

AB - OBJECTIVE: To study the bioequivalence of methylprednisolone (MP) tablets in healthy volunteers. METHOD: A rapid and sensitive RP-HPLC assay was modified for the determination of the drug levels in plasma. In a randomized two-way crossover design, 40 mg single dose po domestic (B) and imported (A, Medrol™) MP tablets, respectively, were given to 18 male healthy volunteers. The parameters were estimated by non-compartment model with a statistic analysis of ANOVA and two one-side t-test. RESULTS: The tmax, cmax, t1/2 and AUC0-∞ of tablet-B and-A were (1.9 ± 0.5) h and (2.1 ± 0.5) h, (597.6 ± 119.8) ng·mL-1 and (572.6 ± 121.7) ng·mL-1, (2.2 ± 0.4) h and (2.3 ± 0.4) h, (2528.4 ± 558.8) h·ng·mL-1 and (2571.2 ± 647.4) h·ng·mL-1, respectively. The mean relative bioavailability of the tablet-B vs A was 99.62%. There was no significant difference between the two products. CONCLUSION: The results suggested that these two products were bioequivalent.

KW - Bioequivalence

KW - HPLC

KW - Methylprednisolone

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M3 - Article

AN - SCOPUS:0035032924

SN - 1001-2494

VL - 36

SP - 261

EP - 264

JO - Chinese Pharmaceutical Journal

JF - Chinese Pharmaceutical Journal

IS - 4

ER -

Study on bioequivalence of domestic methylprednisolone tablets

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