Bioequivalence study of Albendazole 400 mg tablets in Chinese population
Trial overview
Area under the plasma concentration versus time curve from time zero to time t [AUC(0-t)] of Albendazole.
Timeframe: 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
Timeframe: 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
Timeframe: 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
Time to reach maximum plasma concentration (Tmax) of Albendazole
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Participation criteria
- 1) Male aged from 18 years up to 40 years (inclusive).
- 2) Body mass index within the range of 19-24kg/m^2.
- 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.
- 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.
- 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 a) 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); b) 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; c) History of gastrointestinal bleeding or peptic ulcer; d) Asthma e) History of liver disease 4) Medication a) Use of any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing b) Current or regular use of any prescription or over-the-counter medication, any other ABZ containing products, and traditional Chinese medicine. 5) Smoking a) Subjects who are current smokers or non-smokers of less than 3 months; b) Prior (within seven days of dosing) or current use of any other nicotine containing products, including nicotine replacement therapy. 6) Blood a) Blood donation ≥ 500 ml within 90 days before the first study session. b) Plasma donation within the 90 days before the first study session.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.