Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

Helminthiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755637
• Other study ID #: O7921353
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2012
• Last updated: July 11, 2013
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Helminthiasis

Intervention

Drug:
• Albendazole
Albendazole tablets 400 mg

Locations

Country	Name	City	State
China	Central Hospital of China Aerospace Corporation	Beijing	Beijing
China	Tongji Hospital, Medical College Huazhong	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Primary	AUC [0-infinity (Inf)] of Albendazole	AUC (0-inf) was evaluated using the trapezoid rule.	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	No
Primary	Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole	Cmax was depicted from plasma concentration of Albendazole.	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	No
Secondary	Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole	Tmax was time at which Cmax of Albendazole was reached.	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	No
Secondary	AUC (0-t) of Active Metabolite - Albendazole Sulphoxide	AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.	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	No
Secondary	AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide	AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.	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	No
Secondary	Cmax of Active Metabolite - Albendazole Sulphoxide	Cmax was depicted from plasma concentration of Albendazole.	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	No