Clinical Trial: Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-dose, Two-centre, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Two Kinds of AlbendazoleTablet Formulations in Healthy Chinese Adult Males

Brief Summary: The purpose of the study is to compare the pharmacokinetic profiles of two Albendazole tablet formulations manufactured under the different granulation processes in healthy Chinese adult males.

Detailed Summary:

Due to the product manufacture process change in Albendazole oral formulation from ethanol based granulation process to aqua based granulation process, State Food and Drug Administration officially requested Tianjin Smith Kline and French Laboratories to carry out a Bioequivalence study to demonstrate bioequivalence between the manufacturing processes. This trial will be conducted to support the official requirement via the comparison of the pharmacokinetic profiles between both the drugs manufactured under the different processes.

After oral administration, Albendazole is quickly oxidized into its pharmacologically active metabolite, Albendazole sulphoxide (ABZ-SO. Due to extensive metabolism and limited absorption, plasma concentration of ABZ after oral administration was found to be too low to be measured. Thus, this trial will also compare the pharmacokinetic profiles of ABZ-SO manufactured using different solvents.

Sponsor: GlaxoSmithKline

Current Primary Outcome:

• Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole. [ Time Frame: Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr ]
  AUC (0-t) was evaluated using the trapezoid rule.
• AUC [0-infinity (Inf)] of Albendazole [ Time Frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr ]
  AUC (0-inf) was evaluated using the trapezoid rule.
• Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole [ Time Frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr ]
  Cmax was depicted from plasma concentration of Albendazole.

Original Primary Outcome:

• AUC0-t [ Time Frame: 36 hours ]
  plasma concentration versus time curve from time zero to time t (36 hours)
• AUC0-inf [ Time Frame: 36 hours ]
  area under the plasma concentration versus time curve from time zero extrapolated to infinity
• Cmax [ Time Frame: 36 hours ]
  the highest observed plasma concentration

Current Secondary Outcome:

• Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole [ Time Frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr ]
  Tmax was time at which Cmax of Albendazole was reached.
• AUC (0-t) of Active Metabolite - Albendazole Sulphoxide [ Time Frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr ]
  AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.
• AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide [ Time Frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr ]
  AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.
• Cmax of Active Metabolite - Albendazole Sulphoxide [ Time Frame: Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr ]
  Cmax was depicted from plasma concentration of Albendazole.

Original Secondary Outcome:

• Tmax [ Time Frame: 36 hours ]
  compare the pharmacokinetics of Albendazole sulfoxide between the drugs investigated in terms of Tmax
• AUC0-t [ Time Frame: 36 hours ]
  compare the pharmacokinetics of Albendazole sulfoxide between the drugs investigated in terms of AUC0-t
• AUC0-inf [ Time Frame: 36 hours ]
  compare the pharmacokinetics of Albendazole sulfoxide between the drugs investigated in terms of AUC0-inf
• Cmax [ Time Frame: 36 hours ]
  compare the pharmacokinetics of Albendazole sulfoxide between the drugs investigated in terms of Cmax

Information By: GlaxoSmithKline

Dates:
Date Received: December 19, 2012
Date Started: April 2012
Date Completion:
Last Updated: July 11, 2013
Last Verified: May 2013