Healthy
Conditions
Keywords
Bioequivalence
Brief summary
This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.
Detailed description
Serial blood samples will be obtained for PK evaluation.
Interventions
DRUGBetrixaban
Sponsors
Portola Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents. * A healthy man or woman between the ages of 18 and 60 * Has no clinically significant findings in medical history, physical examination, EKG and vital signs * Weighs \> 45 kg (99 lbs.) and has body mass index (BMI) \< 30 kg/m2 * Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods * Is a non-smoker or light smoker (no more than the equivalent of five cigarettes per day) and agrees to abstain from smoking for the duration of each of the study in-house periods
Exclusion criteria
* None of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence analysis using total area under the curve (Total AUC) after a single dose of Betrixaban in healthy subjects | 120 hours |
| Bioequivalance analysis using peak concentration in plasma (Cmax) after a single dose of Betrixaban in healthy volunteers | 120 hours |
Outcome results
None listed