Bioequivalence Study of Capsule and Tablet Formulations of TA-8995

Xention

Status and phase: Completed; Phase 1

Conditions: Dyslipidaemia

Treatments: Drug: TA-8995

Study type: Interventional

Funder types: Industry

Identifiers

NCT02523391

TA-8995-08

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Treatment Period 1

Experimental group

Description:

Either 5mg TA-8995 Capsule or Tablet

Treatment:

Drug: TA-8995

Drug: TA-8995

Treatment Period 2

Experimental group

Description:

Either 5mg TA-8995 Capsule or Tablet

Treatment:

Drug: TA-8995

Drug: TA-8995