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A Study of Prasugrel in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01648790
Recruitment Status : Completed
First Posted : July 24, 2012
Results First Posted : November 5, 2013
Last Update Posted : November 5, 2013
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Prasugrel ODT1 - Tablet Drug: Prasugrel ODT2 - Tablet Drug: Prasugrel ODT2 - Suspension Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects
Study Start Date : July 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Prasugrel

Arms and Interventions
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Arm Intervention/treatment
Experimental: 5 mg Prasugrel (ODT1)
5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state.
 Drug: Prasugrel ODT1 - Tablet
Administered orally as tablet.
Other Names:
  • LY640315
  • Effient
  • Efient
Experimental: 5 mg Prasugrel (ODT2)
5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state.
 Drug: Prasugrel ODT2 - Tablet
Administered orally as tablet.
Other Names:
  • LY640315
  • Effient
  • Efient
Experimental: 5 mg Prasugrel (ODT2)-Suspension
5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.
 Drug: Prasugrel ODT2 - Suspension
Administered orally as suspension.
Other Names:
  • LY640315
  • Effient
  • Efient
Experimental: 5 mg Prasugrel (ODT2)-Fed
5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast.
 Drug: Prasugrel ODT2 - Tablet
Administered orally as tablet.
Other Names:
  • LY640315
  • Effient
  • Efient
Experimental: 2 mg Prasugrel (ODT2)
2 mg Prasugrel as ODT2 formulation administered once in the fasted state.
 Drug: Prasugrel ODT2 - Tablet
Administered orally as tablet.
Other Names:
  • LY640315
  • Effient
  • Efient


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation [ Time Frame: Predose through 8 Hours Post Dose ]
    Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.

  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation [ Time Frame: Predose through 8 Hours Post Dose ]
    AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.


Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State [ Time Frame: Predose through 8 Hours Post Dose ]
    Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.

  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State [ Time Frame: Predose through 8 Hours Post Dose ]
    AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648790


Locations
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United States, Texas
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
Sponsors and Collaborators
Eli Lilly and Company
Daiichi Sankyo, Inc.
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01648790     History of Changes
Other Study ID Numbers: 14686
H7T-EW-TAEQ ( Other Identifier: Eli Lilly and Company )
First Posted: July 24, 2012    Key Record Dates
Results First Posted: November 5, 2013
Last Update Posted: November 5, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Prasugrel Hydrochloride
Platelet Aggregation Inhibitors