Phase 1
Completed N=20
A Study of Prasugrel in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01648790 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation — 28.6; 28.1 nanograms per milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation |
28.6; 28.1 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation |
27.1; 26.8 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State |
28.6; 28.1; 31.5; 7.79; 8.81 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State |
27.1; 26.8; 27; 20.8; 8.97 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01648790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.