A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

NCT01363999 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-12-17

Study results available
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Summary

A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.

Conditions

  • Healthy Volunteer

Interventions

DRUG

atorvastatin

single dose of atorvastatin on day 1

DRUG

dalcetrapib

single dose of dalcetrapib on day 1

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01363999 on ClinicalTrials.gov