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Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

NCT ID: NCT02523391

Last Updated: 2016-01-29

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-11-30

Brief Summary

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The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.

Detailed Description

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Conditions

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Dyslipidaemia

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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Treatment Period 1

Either 5mg TA-8995 Capsule or Tablet

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Capsule

TA-8995

Intervention Type DRUG

Tablet

Treatment Period 2

Either 5mg TA-8995 Capsule or Tablet

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Capsule

TA-8995

Intervention Type DRUG

Tablet

Interventions

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TA-8995

Capsule

Intervention Type DRUG

TA-8995

Tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males aged 18-55
* Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive

Exclusion Criteria

* Subject has a known hypersensitivity to any of the inactive ingredients of the study treatments.
* Subject has any other condition which, in the Investigator's opinion will interfere with the study.
* Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xention Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Covance Clinical Research Unit Ltd

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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TA-8995-08

Identifier Type: -

Identifier Source: org_study_id