Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects

NCT05841446 | Completed Phase 1

• 1 other identifier: DS-APSBBE-2020
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the single-center, open, randomized, single-dose, two-cycle, two-sequence, cross-over bioequivalence of test preparation apixaban tablet 2.5mg and reference preparation 2.5mg in healthy adult subjects in fasting and fed state

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  48hours

• Area under the plasma concentration versus time curve (AUC0-t)

  Evaluation of Area under the plasma concentration versus time curve (AUC0-t)

  48hours

• Area under the plasma concentration versus time curve (AUC0-∞)

  Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)

  48hours

Study Arms (2)

Test/reference

EXPERIMENTAL

Subjects first receive a single-dose of 2.5mg test apixaban tablet (T, produced by Disha Pharmaceutical Group Co., Ltd. China) in the first treatment period and to receive the reference (R, Bristol-Myers Squibb Manufacturing Company,USA )in the second treatment period.

Drug: test apixaban tablets; Drug: reference apixaban tablets

Reference/test

EXPERIMENTAL

Subjects first receive a single-dose of 2.5mg reference apixaban tablet (R, Bristol-Myers Squibb Manufacturing Company, USA )in the first treatment period and to receive test tablet (T, produced by Disha Pharmaceutical Group Co., Ltd. China) in the second treatment period.

Drug: test apixaban tablets; Drug: reference apixaban tablets

Interventions

test apixaban tablets DRUG

specification: 2.5 mg, manufacturer: Disha Pharmaceutical Group Co., Ltd., Shandong, China

Reference/test; Test/reference

reference apixaban tablets DRUG

specification: 2.5 mg, manufacturer: Bristol-Myers Squibb Manufacturing Company, USA

Reference/test; Test/reference

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions;
• Be able to complete the study according to the requirements of the test plan;
• Subjects (including male subjects) agreed to have no pregnancy plan and to voluntarily take effective contraceptive measures within 3 months from the end of the study after signing the informed consent;
• Male and female subjects aged 18 years and above;
• Male subjects weigh at least 50kg. Female subjects weighed at least 45 kilograms. Body Mass index = weight (kg)/height 2 (m2), within the range of 18.0 to 26.0kg/m2 (including the critical value)

You may not qualify if:

• Prior disease of the neuropsychiatric, respiratory, cardiovascular, digestive, hematolymphatic, hepatic or renal insufficiency, endocrine, skeletal-muscular system, or other disease, and the investigator determines that this prior medical history may have an impact on drug metabolism or safety;
• Persons who have smoked more than 5 cigarettes per day on average during the 3 months prior to screening;
• Persons with a history of specific allergies (asthma, urticaria, eczema, etc.), allergic persons (e.g., allergy to two or more drugs, food), known hypersensitivity to this drug component or (including but not limited to) rivaroxaban;
• Lactose intolerant individuals (e.g., those who have experienced diarrhea from drinking milk)
• History of alcohol abuse (≥ 14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits over 40 degrees, or 100 ml of wine) within the last year;
• Have donated blood or lost ≥ 400 ml of blood within 3 months prior to the trial, or intend to donate blood or blood components during or within 3 months after the trial;
• A history of dysphagia or any gastrointestinal disorder that interferes with drug absorption
• Use of any recombinant cytochrome P450 3A4 (CYP3A4) or permeability glycoprotein (P-gp) inhibitors (e.g., ketoconazole, itraconazole, voriconazole and posaconazole, ritonavir, diltiazem, naproxen, amiodarone, verapamil, quinidine, famotidine, macrolides, nitroimidazoles, sedative-hypnotics, fluoroquinolones, antihistamines), CYP3A4 and P-gp inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital or St. John's wort, omeprazole, glucocorticoids);
• Any anticoagulant, platelet aggregation inhibitor, selective 5-hydroxytryptamine reuptake inhibitor or 5-hydroxytryptamine norepinephrine reuptake inhibitor or non-steroidal anti-inflammatory drug used within 30 days prior to the trial and drugs that may cause severe bleeding, such as common heparin and heparin derivatives (including low molecular weight heparin), oligosaccharides that inhibit coagulation factor Xa (e.g. sulforaphane sodium), prothrombin II direct inhibitors thrombolytic agents, thienopyridines (e.g., clopidogrel), dipyridamole, dextran, sulpiride, vitamin K antagonists, and other oral anticoagulants;
• Taking any prescription, over-the-counter, herbal or nutraceutical medication within 14 days prior to the administration of the study drug;
• have taken a special diet (caffeine, alcohol, or xanthine-rich foods and beverages, including dragon fruit, mango, grapefruit, chocolate, or tea), or smoked, or had a significant change in exercise habits, or other factors affecting drug absorption, distribution, metabolism, or excretion within 48 h prior to the administration of the study drug
• Those with a positive alcohol screening test;
• Those who have participated in another clinical trial of a drug and taken the test drug within 3 months prior to taking the study drug
• Abnormalities of clinical significance as judged by the clinician, including physical examination, vital signs examination, electrocardiogram examination or clinical laboratory examination (including routine blood, urine, blood biochemistry, coagulation function examination)
• Those with creatinine clearance ≤ 50 mL/min;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

Study Design

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

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: March 2, 2021
• Primary Completion: March 17, 2021
• Study Completion: April 7, 2021
• Last Updated: May 3, 2023

Record last verified: 2023-05

Locations

CN (1)