Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

Xention Ltd26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidaemia

Interventions

TA-8995DRUG

Capsule

TA-8995DRUG

Tablet

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Covance Clinical Research Unit Ltd

Leeds, United Kingdom

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations

Time frame: 72 hours

Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations

Time frame: 72 hours

Data from ClinicalTrials.gov

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