Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population

NCT01755637 | Completed Phase 1 Results

• 1 other identifier: O7921353
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Helminthiasis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (4)

• Time to Reach Maximum Plasma Concentration (Tmax) 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

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

  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 Active Metabolite - Albendazole Sulphoxide

  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 of Active Metabolite - Albendazole Sulphoxide

  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

Study Arms (2)

Albendazole tablet (Aqua Based)

EXPERIMENTAL

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 tablet (Alcohol Based)

ACTIVE COMPARATOR

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

Drug: Albendazole

Interventions

Albendazole DRUG

Albendazole tablets 400 mg

Albendazole tablet (Alcohol Based); Albendazole tablet (Aqua Based)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

Central Hospital of China Aerospace Corporation

Beijing, Beijing Municipality, 100049, China

Location

Tongji Hospital, Medical College Huazhong

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Helminthiasis

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 24, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 15, 2013
• Results First Posted: July 15, 2013

Record last verified: 2013-05

Locations

CN (2)