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A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects

NCT ID: NCT01289509

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to evaluate the relative bioavailability (BA) of two lots of E5501 40 mg tablets administered twice as single oral doses to healthy subjects.

Detailed Description

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This is a randomized, open label, 4- way crossover, replicate design study to evaluate the bioavailability (BA) of E5501 new Phase 3 formulation Lot P97001ZZB 40 mg tablet manufactured July, 2009 (Treatment A ,reference drug) relative to Lot P01010ZZA 40 mg tablet manufactured January, 2010 (Treatment B, test drug) administered to 42 healthy male and female subjects.

Conditions

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Idiopathic Thrombocytopenia Purpura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental 1

Drug: E5501

Group Type EXPERIMENTAL

E5501

Intervention Type DRUG

Lot P01010ZZA (test) single oral doses of 40 mg tablets.

Experimental 2

Drug: E5501

Group Type EXPERIMENTAL

Drug: E5501

Intervention Type DRUG

Lot P97001ZZB (reference) single oral doses of 40 mg tablets.

Interventions

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E5501

Lot P01010ZZA (test) single oral doses of 40 mg tablets.

Intervention Type DRUG

Drug: E5501

Lot P97001ZZB (reference) single oral doses of 40 mg tablets.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal healthy adult male or female subjects age greater than or equal to 18 years and less than or equal to 55 years old.
* Body mass index greater than or equal to 18 kg/m2 and less than or equal to 32 kg/m2 at the time of screening.
* Platelet count between 120x109/L and 250x109/L.
* Women of childbearing potential must agree to use a double barrier method of contraception during the Randomization Phase of the study.

Exclusion Criteria

* Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pharmacokinetics (PK)of the study drug.
* Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of the first study drug administration.
* Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history, e.g., history of splenectomy.
* History of venous or arterial thrombotic disease or other hypercoaguable state.
* Hemoglobin level less than 11.5 g/dL for females and 13.5g /dL for males
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franklin Johnson

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

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PRA

Lenexa, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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E5501-A001-007

Identifier Type: -

Identifier Source: org_study_id