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Colesevelam film-coated

Phase 1

Healthy | Small molecule | Other |Sanofi|Last Updated: May 5, 2015

Target and mechanism

ModalitySmall molecule

Also known as Colesevelam hydrochloride film-coated tablets (Cholestagel)

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Colesevelam film-coated · 1 trial · 1 indication

Phase 1 1
NCT00692250A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy VolunteersHealthy
COMPLETED14 Analytics
PHASE1COMPLETED
A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
Healthy
NCT0069225014
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Study Endpoints

Primary Endpoints

Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))
12 weeks

Secondary Endpoints

Safety
12
Tolerability
12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Interventions

NameTypeDescription
Colesevelam hydrochloride film-coated tablets (Cholestagel)DRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject must have a body mass index (BMI) between 19 and 25 inclusive * Medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ECGs. * Give voluntary written informed consent to participate in the study Exclusion Criteria: * Hi...

Countries:Netherlands
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