Skip to main content
OpenTrials
Completed

NCT Number: NCT02523391

Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidaemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TA-8995

Drug

Capsule

Primary outcomes

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

    Time frame: 72 hours

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

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Xention Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2015
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.