Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

A Phase I, Randomised, Open-label Cross-over Bioequivalence Study of Capsule and Tablet Formulations of TA-8995 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02523391

Enrollment

Registered

2015-08-14

Start date

2015-07-31

Completion date

2015-11-30

Last updated

2016-01-29

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

Conditions

Dyslipidaemia

Brief summary

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.

Interventions

DRUGTA-8995

Capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations	72 hours
Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations	72 hours

Countries

United Kingdom

Outcome results

None listed

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