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A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

NCT ID: NCT01363999

Last Updated: 2019-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

RO5317116/F01 bilayer tablet

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

single dose of atorvastatin on day 1

dalcetrapib

Intervention Type DRUG

single dose of dalcetrapib on day 1

B

RO5317116/F03 bilayer tablet

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

single dose of atorvastatin on day 1

dalcetrapib

Intervention Type DRUG

single dose of dalcetrapib on day 1

C

RO5317116/F04 active-coated tablet

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

single dose of atorvastatin on day 1

dalcetrapib

Intervention Type DRUG

single dose of dalcetrapib on day 1

D

RO4607381/F49 tablet

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

single dose of atorvastatin on day 1

dalcetrapib

Intervention Type DRUG

single dose of dalcetrapib on day 1

Interventions

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atorvastatin

single dose of atorvastatin on day 1

Intervention Type DRUG

dalcetrapib

single dose of dalcetrapib on day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers, 18 to 55 years of age, inclusive

Exclusion Criteria

* Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
* Clinically significant abnormal laboratory values
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Christchurch, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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WP25642

Identifier Type: -

Identifier Source: org_study_id