BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects
An Open-label, Randomized, 2-sequence, 2-period, Fasted, Single Dose, Oral Administration, Crossover Study to Evaluate the Bioequivalence of YHP1807 Tablets 2.5 mg and YHR1901 Tablets 2.5 mg in Healthy Volunteers
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2020
CompletedFirst Submitted
Initial submission to the registry
June 9, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedJune 16, 2022
June 1, 2022
17 days
June 9, 2022
June 13, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
AUCt
AUCt of Rivaroxaban
0-36 hours
Cmax
Cmax of Rivaroxaban
0-36 hours
Secondary Outcomes (3)
AUCinf
0-36 hours
Tmax
0-36 hours
t1/2
0-36 hours
Study Arms (2)
Group1
EXPERIMENTAL17 subjects, Cross-over, Single dose of comparator on day1, YHP1807 on day8
Group2
ACTIVE COMPARATOR17 subjects, Cross-over, Single dose of YHP1807 on day1, comparator on day8
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
Related Publications (1)
Moon SJ, Kim Y, Kim SY, Jeon JY, Song E, Lim Y, Kim MG. Comparative pharmacokinetics of two formulations of 2.5-mg rivaroxaban in healthy Korean subjects. Int J Clin Pharmacol Ther. 2023 Mar 5. doi: 10.5414/CP204335. Online ahead of print.
PMID: 36871246DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2022
First Posted
June 14, 2022
Study Start
January 28, 2020
Primary Completion
February 14, 2020
Study Completion
February 14, 2020
Last Updated
June 16, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Beginning 1 year and ending 5 years after all trial endpoints were assessed
- Access Criteria
- Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to ejsong@yuhan.co.kr.
De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to ejsong@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov).