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orlistat experimental dose

Phase 1

Overweight | Small molecule | Metabolic |GSK plc|Last Updated: Jan 28, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

orlistat experimental dose · 1 trial · 1 indication

Phase 1 1
NCT01550926A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage FormsOverweight
COMPLETED48 Analytics
PHASE1COMPLETED
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
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Study Endpoints

Primary Endpoints

Fecal fat excretion
9 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR60 mg orlistat
Arm 2ACTIVE_COMPARATOR120 mg orlistat (2 X 60 mg capsules)
Arm 3EXPERIMENTALorlistat experimental formulation

Interventions

NameTypeDescription
120 mg orlistatDRUG2 X60 mg capsule
60 mg orlistatDRUG60 mg orlistat
orlistat experimental doseDRUGexperimental
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * age: 18-60 years * Body Mass Index: 25-33 Exclusion Criteria: * gastrointestinal disease * organ transplant * HIV, hepatitis B or C * food allergies * alcohol or other substance abuse * smoking

Countries:United Kingdom
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