CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
Prasugrel ODT1 - Tablet +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01648790
NCT01648790Phase 1Completed

Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects

Eli Lilly and Company·interventional·Posted Jul 24, 2012·Updated Nov 5, 2013

In Brief

A Phase 1 clinical trial evaluating Prasugrel ODT1 - Tablet, Prasugrel ODT2 - Tablet, and 1 other intervention for Healthy Volunteers. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsDaiichi Sankyo

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2012
Enrollment StartJul 1, 2012
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.9 years ago

Interventions

Prasugrel ODT1 - Tabletdrug

Administered orally as tablet.

Prasugrel ODT2 - Tabletdrug

Administered orally as tablet.

Prasugrel ODT2 - Suspensiondrug

Administered orally as suspension.