Interaction Study SLV337/Simvastatin

Solvay

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin; Drug: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00924430

2009-010392-24

S337.1.002

Details and patient eligibility

About

To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Volunteers with Body Mass Index 18.0-28.0 kg/m2

Exclusion criteria

• Clinically relevant medical history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

1

Other group

Treatment:

Drug: Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin

2

Other group

Treatment:

Drug: Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin