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Albendazole

Phase 1

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

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

Clinical trial landscape

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 for helminthiasis, a condition caused by parasitic worm infections. It is being developed as a small molecule treatment for this infectious disease. The drug is currently in clinical development and is not yet approved for this use.

Who makes Albendazole?

Albendazole is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating helminthiasis.

What phase is Albendazole in?

Albendazole is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still undergoing clinical evaluation for the treatment of helminthiasis.

What clinical trials is Albendazole in?

Albendazole has one completed Phase 1 clinical trial, identified as NCT01755637. This was a bioequivalence study of Albendazole 400 mg tablets conducted in a Chinese population. The trial enrolled 56 healthy male volunteers and was active-controlled, though it was not double-blinded.

Is Albendazole the same as any other drug?

Albendazole is the drug name provided, and no alternative names have been mentioned. It is a small molecule being studied for helminthiasis. If you are looking for other names, they have not been specified in the available information.