Trial Outcomes & Findings for A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet (NCT NCT01430091)

NCT ID: NCT01430091

Last Updated: 2012-11-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Pre-dose up to 8 hours post-dose after each treatment

Results posted on

2012-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Received 5 milligrams (mg) prasugrel as either the clinical tablet or as an orally disintegrating tablet (ODT).
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants n=18 Participants Total Number of Study Participants
Age Continuous	37.1 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose up to 8 hours post-dose after each treatment

Population: Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.

Outcome measures

Outcome measures
Measure	Clinical Tablet n=18 Participants 5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.	ODT on Top of Tongue n=18 Participants 5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.	ODT on Top of Tongue With Juice Chaser n=18 Participants 5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.	ODT Chewed and Swallowed n=18 Participants 5-mg prasugrel ODT chewed and swallowed, no liquid given.	ODT Placed Under the Tongue n=18 Participants 5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM)	43.3 nanogram * hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 27.0	42.7 nanogram * hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 25.0	42.3 nanogram * hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 29	41.0 nanogram * hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 32	42.0 nanogram * hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 30

PRIMARY outcome

Timeframe: Pre-dose up to 8 hours post-dose after each treatment

Population: Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.

Outcome measures

Outcome measures
Measure	Clinical Tablet n=18 Participants 5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.	ODT on Top of Tongue n=18 Participants 5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.	ODT on Top of Tongue With Juice Chaser n=18 Participants 5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.	ODT Chewed and Swallowed n=18 Participants 5-mg prasugrel ODT chewed and swallowed, no liquid given.	ODT Placed Under the Tongue n=18 Participants 5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel's Active Metabolite (PRAS-AM)	47.3 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 48	47.6 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 19	32.3 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 37	38.3 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 47	41.9 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 37

PRIMARY outcome

Timeframe: Pre-dose up to 8 hours post-dose after each treatment

Population: Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.