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A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)

NCT01358344 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2015-09-29

No results posted yet for this study

Summary

The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Pantoprazole

40 mg delayed-release tablet administered orally in the morning of Days 1-7

DRUG

SCH 530348 (high percentage)

2.5 mg tablet containing \~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5

DRUG

SCH 530348 (standard percentage)

2.5 mg tablet containing \~23% API as free base (STANDARD) administered orally on the morning of Day 5

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358344 on ClinicalTrials.gov