Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

NCT04424381 | Completed Phase 1 DMC

• 1 other identifier: QL-YK4-012-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet.

Conditions

Healthy Subjects

Keywords

rivaroxaban; pharmacokinetics; bioequivalence

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  94 days

• Area under the plasma concentration versus time curve (AUC)0-t

  Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

  94 days

• Area under the plasma concentration versus time curve (AUC)0-∞

  Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

  94 days

Secondary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events

  94 days

• Incidence of abnormal blood pressure

  94 days

• Incidence of abnormal temperature

  94 days

• Incidence of abnormal pulse

  94 days

• Incidence of abnormal electrocardiogram waveform

  94 days

Study Arms (2)

Rivaroxaban 20 MG Oral Tablet [Xarelto]

ACTIVE COMPARATOR

rivaroxaban oral tablet \[Xarelto\] at a single oral dose of 20 mg

Drug: Rivaroxaban 20 MG Oral Tablet

Rivaroxaban 20 MG Oral Tablet

EXPERIMENTAL

rivaroxaban oral tablet at a single oral dose of 20 mg

Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]

Interventions

Rivaroxaban 20 MG Oral Tablet [Xarelto] DRUG

The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet \[Xarelto\].

Rivaroxaban 20 MG Oral Tablet

Rivaroxaban 20 MG Oral Tablet DRUG

The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.

Rivaroxaban 20 MG Oral Tablet [Xarelto]

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female aged 18 and above.
• The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
• The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
• The subjects have no family planning within 3 months and could select contraceptive method.Before the study, all subjects
• Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

You may not qualify if:

• Being allergy to the study medications, smoking, alcohol abuse.
• Participation in another clinical trial within 3 months.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Interventions

Rivaroxaban; Tablets

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• yu Cao

  the study director of phase I clinical research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study was designed as a four-period complete and replicate crossover

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: June 4, 2019
• Primary Completion: September 5, 2019
• Study Completion: September 20, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)