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Albendazole

Phase 3

Helminthiasis | Small molecule | Infectious Disease |GSK plc|Trials Updated: Jul 15, 2013

Albendazole development status

Highest phase Phase 3 run by National Institute of Allergy and Infectious Diseases (NIAID) (NCT00133458)
Phase scored for GSKPhase 1
Registered trials 10 across 7 sponsors since Aug 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Albendazole clinical trials

Albendazole · 1 trial · 1 indication

Phase 1 1
NCT01755637Bioequivalence Study of Albendazole 400 mg Tablets in Chinese PopulationHelminthiasis
COMPLETED56 Analytics
PHASE1COMPLETED
Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population
HelminthiasisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

AUC [0-infinity (Inf)] 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-inf) was evaluated using the trapezoid rule.

Maximum Observed Plasma Concentration [Cmaximum (Max)] 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

Cmax was depicted from plasma concentration of Albendazole.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Albendazole tablet (Aqua Based)EXPERIMENTALAlbendazole tablets 400 milligram (mg) manufactured under aqua based solvent condition taken orally with 200 millilitre (mL) of water as single dose treatment.
Albendazole tablet (Alcohol Based)ACTIVE_COMPARATORAlbendazole tablets 400 mg manufactured under ethanol based solvent condition taken orally with 200 mL of water as single dose treatment.

Interventions

NameTypeDescription
AlbendazoleDRUGAlbendazole tablets 400 mg
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersYes
Study Sites2

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. Negati...

Countries:China
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Frequently asked questions about Albendazole

What is Albendazole used for?

Albendazole is used to treat helminthiasis, a parasitic worm infection. It is an infectious disease therapy developed by GSK plc under the ticker GSK. The drug is a small molecule and is also known as Albendazole 400 mg. Clinical development has focused on a bioequivalence study in a Chinese population.

Who makes Albendazole?

Albendazole is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor associated with the clinical trial of Albendazole 400 mg tablets. GSK plc is a global pharmaceutical company, and this asset falls within its infectious disease portfolio.

What phase is Albendazole in?

Albendazole is in Phase 1 clinical development. The only listed trial is a completed Phase 1 bioequivalence study of Albendazole 400 mg tablets. No active trials are currently recorded. The drug remains investigational and is not described as approved in the available development information.

What clinical trials is Albendazole in?

Albendazole has been studied in one completed clinical trial, NCT01755637, titled Bioequivalence Study of Albendazole 400 mg Tablets in Chinese Population. It was a Phase 1, randomized, active-controlled trial with 56 enrolled male healthy volunteers aged 18 years and older, conducted in China.