Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01755637
First received: December 19, 2012
Last updated: July 11, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Helminthiasis
Drug: Albendazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cmax was depicted from plasma concentration of Albendazole.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cmax was depicted from plasma concentration of Albendazole.


Enrollment: 56
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albendazole tablet (Aqua Based)
Albendazole tablets 400 milligram (mg) manufactured under aqua based solvent condition taken orally with 200 millilitre (mL) of water as single dose treatment.
Drug: Albendazole
Albendazole tablets 400 mg
Active Comparator: Albendazole tablet (Alcohol Based)
Albendazole tablets 400 mg manufactured under ethanol based solvent condition taken orally with 200 mL of water as single dose treatment.
Drug: Albendazole
Albendazole tablets 400 mg

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male aged from 18 years up to 40 years (inclusive).
  2. Body mass index within the range of 19-24kg/m^2.
  3. Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
  4. Negative for serum hepatitis B surface antigen, hepatitis C antibody and antibody of HIV.

Exclusion Criteria:

  1. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  2. Substance abuse: Recent history (within the last year) of alcohol or other substance abuse or failed to pass drugs of abuse screen and/or alcohol screen test.
  3. Disease

    1. Current or recurrent disease that could affect the action, absorption or distribution of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, abnormal liver function tests, renal insufficiency, congestive heart failure);
    2. Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures;
    3. History of gastrointestinal bleeding or peptic ulcer;
    4. Asthma
    5. History of liver disease
  4. Medication

    1. Use of any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing
    2. Current or regular use of any prescription or over-the-counter medication, any other ABZ containing products, and traditional Chinese medicine.
  5. Smoking

    1. Subjects who are current smokers or non-smokers of less than 3 months;
    2. Prior (within seven days of dosing) or current use of any other nicotine containing products, including nicotine replacement therapy.
  6. Blood

    1. Blood donation ≥ 500 ml within 90 days before the first study session.
    2. Plasma donation within the 90 days before the first study session.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755637

Locations
China, Beijing
Central Hospital of China Aerospace Corporation
Beijing, Beijing, China, 100049
China, Hubei
Tongji Hospital, Medical College Huazhong
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01755637     History of Changes
Other Study ID Numbers: O7921353
Study First Received: December 19, 2012
Results First Received: March 21, 2013
Last Updated: July 11, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Helminthiasis
Parasitic Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 29, 2014