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

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

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

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
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 |
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 |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT01648790 |
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 |
Prasugrel Hydrochloride Platelet Aggregation Inhibitors |