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A Study of Prasugrel in Healthy Participants

NCT ID: NCT01648790

Last Updated: 2013-11-05

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.

Detailed Description

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The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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5 mg Prasugrel (ODT1)

5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state.

Group Type EXPERIMENTAL

Prasugrel ODT1 - Tablet

Intervention Type DRUG

Administered orally as tablet.

5 mg Prasugrel (ODT2)

5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state.

Group Type EXPERIMENTAL

Prasugrel ODT2 - Tablet

Intervention Type DRUG

Administered orally as tablet.

5 mg Prasugrel (ODT2)-Suspension

5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.

Group Type EXPERIMENTAL

Prasugrel ODT2 - Suspension

Intervention Type DRUG

Administered orally as suspension.

5 mg Prasugrel (ODT2)-Fed

5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast.

Group Type EXPERIMENTAL

Prasugrel ODT2 - Tablet

Intervention Type DRUG

Administered orally as tablet.

2 mg Prasugrel (ODT2)

2 mg Prasugrel as ODT2 formulation administered once in the fasted state.

Group Type EXPERIMENTAL

Prasugrel ODT2 - Tablet

Intervention Type DRUG

Administered orally as tablet.

Interventions

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Prasugrel ODT1 - Tablet

Administered orally as tablet.

Intervention Type DRUG

Prasugrel ODT2 - Tablet

Administered orally as tablet.

Intervention Type DRUG

Prasugrel ODT2 - Suspension

Administered orally as suspension.

Intervention Type DRUG

Other Intervention Names

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LY640315 Effient Efient LY640315 Effient Efient LY640315 Effient Efient

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2)

Exclusion Criteria

* No known allergies to Prasugrel or related compound
* No regular alcohol intake greater than 21 units per week for males or 14 units per week for females
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H7T-EW-TAEQ

Identifier Type: OTHER

Identifier Source: secondary_id

14686

Identifier Type: -

Identifier Source: org_study_id