Back to results

Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

Primary Purpose

Helminthiasis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Albendazole

About this trial

This is an interventional treatment trial for Helminthiasis

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
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.
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
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.
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.
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.

Sites / Locations

Central Hospital of China Aerospace Corporation
Tongji Hospital, Medical College Huazhong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Albendazole tablet (Aqua Based)

Albendazole tablet (Alcohol Based)

Arm Description

Albendazole tablets 400 milligram (mg) manufactured under aqua based solvent condition taken orally with 200 millilitre (mL) of water as single dose treatment.

Albendazole tablets 400 mg manufactured under ethanol based solvent condition taken orally with 200 mL of water as single dose treatment.

Outcomes

Primary Outcome Measures

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.

AUC (0-t) was evaluated using the trapezoid rule.

AUC [0-infinity (Inf)] of Albendazole

AUC (0-inf) was evaluated using the trapezoid rule.

Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole

Cmax was depicted from plasma concentration of Albendazole.

Secondary Outcome Measures

Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole

Tmax was time at which Cmax of Albendazole was reached.

AUC (0-t) of Active Metabolite - Albendazole Sulphoxide

AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.

AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide

AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.

Cmax of Active Metabolite - Albendazole Sulphoxide

Cmax was depicted from plasma concentration of Albendazole.

Full Information

NCT ID

NCT01755637

First Posted

December 19, 2012

Last Updated

July 11, 2013

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01755637

Brief Title

Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helminthiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Albendazole tablet (Aqua Based)

Arm Type

Experimental

Arm Description

Albendazole tablets 400 milligram (mg) manufactured under aqua based solvent condition taken orally with 200 millilitre (mL) of water as single dose treatment.

Arm Title

Albendazole tablet (Alcohol Based)

Arm Type

Active Comparator

Arm Description

Albendazole tablets 400 mg manufactured under ethanol based solvent condition taken orally with 200 mL of water as single dose treatment.

Intervention Type

Drug

Intervention Name(s)

Albendazole

Intervention Description

Albendazole tablets 400 mg

Primary Outcome Measure Information:

Title

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.

Description

AUC (0-t) was evaluated using the trapezoid rule.

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

Title

AUC [0-infinity (Inf)] of Albendazole

Description

AUC (0-inf) was evaluated using the trapezoid rule.

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

Title

Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole

Description

Cmax was depicted from plasma concentration 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

Secondary Outcome Measure Information:

Title

Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole

Description

Tmax was time at which Cmax of Albendazole was reached.

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

Title

AUC (0-t) of Active Metabolite - Albendazole Sulphoxide

Description

AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.

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

Title

AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide

Description

AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.

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

Title

Cmax of Active Metabolite - Albendazole Sulphoxide

Description

Cmax was depicted from plasma concentration 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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male aged from 18 years up to 40 years (inclusive). Body mass index within the range of 19-24kg/m^2. Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. Negative for serum hepatitis B surface antigen, hepatitis C antibody and antibody of HIV. Exclusion Criteria: Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 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. Disease 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); 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; History of gastrointestinal bleeding or peptic ulcer; Asthma History of liver disease Medication Use of any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing Current or regular use of any prescription or over-the-counter medication, any other ABZ containing products, and traditional Chinese medicine. Smoking Subjects who are current smokers or non-smokers of less than 3 months; Prior (within seven days of dosing) or current use of any other nicotine containing products, including nicotine replacement therapy. Blood Blood donation ≥ 500 ml within 90 days before the first study session. Plasma donation within the 90 days before the first study session.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

Central Hospital of China Aerospace Corporation

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100049

Country

China

Facility Name

Tongji Hospital, Medical College Huazhong

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

12. IPD Sharing Statement

Learn more about this trial

Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

We'll reach out to this number within 24 hrs