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

A Randomized, Open-Label, 4-Way Crossover Replicate Design 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01289509

Enrollment

Registered

2011-02-03

Start date

2010-12-31

Completion date

2011-05-31

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Thrombocytopenia Purpura

Brief summary

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

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.

Interventions

DRUGE5501

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

DRUGDrug: E5501

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
• To evaluate the bioavailability (BA) , as measured by AUC point estimates of E5501 40 mg tablet Lot P01010ZZA (test) relative to E5501 40 mg tablet Lot P97001ZZB (reference).	96 hours post-dose
To evaluate the bioavailability, as measured by Cmax point estimates of E5501 40 mg tablet Lot P01010ZZA (test) relative to E5501 40 mg tablet Lot P97001ZZB (reference).	96 hours post dose

Secondary

Measure	Time frame
• To assess the intra-subject and inter-subject variability in Cmax following replicate dosing with E5501 40 mg lots	10 weeks
• To assess the intra-subject and inter-subject variability in AUC(0-inf) following replicate dosing with E5501 40 mg lots.	10 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026