Recent Updates
Recently added Catalysts

Albendazole

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01755637Bioequivalence Study of Albendazole 400 mg Tablets in Chinese PopulationPHASE1 COMPLETED 56 — — Apr 1, 2012Jun 1, 2012Jul 15, 20132 China
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria