Status:
COMPLETED
BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects
Lead Sponsor:
Yuhan Corporation
Conditions:
Healthy Volunteer
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The objective of this study was to compare the pharmacokinetic profiles and bioequivalence of rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.
Detailed Description
This study was a randomized, open-label, single-dose, two-period, crossover study which included 34 healthy adult male and female subjects under fasting conditions. A single dose of experimental drug ...
Eligibility Criteria
Inclusion
- Healthy male/female aged 19 to 55 with body mass index(BMI) between 18.5 and 30kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Subjects who has signed a written informed consent voluntarily
Exclusion
- History of clinically significant medical history or current disease
- Hypotension (SBP ≤ 90 mmHg or DBP ≤ 60 mmHg) or hypertension (SBP
- ≥ 140 mmHg or DBP ≥ 90 mmHg).
- AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit
- Total bilirubin \> 2.0 mg/dl
- Volunteers considered not eligible for the clinical trial by the investigator
- Administration of other investigational products within 6 month prior to the first dosing.
Key Trial Info
Start Date :
January 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05418803
Start Date
January 28 2020
End Date
February 14 2020
Last Update
June 16 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907