Bioequivalence Study of Capsule and Tablet Formulations of TA-8995
- Registration Number
- NCT02523391
- Lead Sponsor
- Xention Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Period 2 TA-8995 Either 5mg TA-8995 Capsule or Tablet Treatment Period 1 TA-8995 Either 5mg TA-8995 Capsule or Tablet
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations 72 hours Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations 72 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Covance Clinical Research Unit Ltd
🇬🇧Leeds, United Kingdom