HealthyPhase 1NCT05841446
Bioequivalence Study of Apixaban Tablets in Healthy Chinese Subjects
A Phase 1 study testing test apixaban tablets and reference apixaban tablets in people with Healthy, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- test apixaban tablets and reference apixaban tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2021to 7 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 27Show fewer
- 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;
- Those with coagulation disorders, or those with bleeding tendencies (e.g., frequent recurrent gum bleeding), or those with increased bleeding risk events within the past 6 months, previous intracranial bleeding, gastrointestinal bleeding, purpura, or those who have undergone major surgery within the past 30 days, or those with active pathologic bleeding
- positive for hepatitis B surface antigen, positive for hepatitis C antibodies, positive for HIV antibodies, or positive for primary syphilis screening
- Those with positive substance abuse screening or a history of substance abuse within the past five years
- Subjects with a history of blood or needle sickness, difficulty in blood collection or inability to tolerate venipuncture blood collection
- Subjects who are unable or incapable of complying with ward management regulations
- Subjects who have had a major illness or major surgical procedure within 4 weeks prior to administration of study drug
- Subjects who are unable to complete the trial for personal reasons;
- Subjects who are judged by the investigator to be unfit to participate in the study of this trial
- Female subjects who are breastfeeding or have a positive pregnancy test result during the screening period or during the course of the trial
- Female subjects who are using oral contraceptives 30 days prior to taking the study drug and during the trial
- Female subjects using long-acting estrogen or progestin injections or implant tablets within 6 months prior to study drug administration and during the trial
- Female subjects who had unprotected sex two weeks prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University Phase I Clinical Research Center
Qingdao, Shandong, 266003
About this study
Official title: Single-center, Open, Randomized, Single-dose, Two-cycle, Two-sequence, Crossover Bioequivalence Study to Evaluate the Effects of the Test and the Fed States
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
Read the detailed description
Fasting test: 24 subjects were planned to be enrolled. Each subject was randomly assigned to one of the two groups according to a randomization table. In the first cycle, after fasting for at least 10 h, all subjects received the corresponding study drug orally in sequence starting with the first subject in the fasted state, with one group of subjects receiving the test preparation apixaban tablets 2.5 mg orally and the other group receiving the reference preparation apixaban tablets 2.5 mg orally, and then 7 days later crossed over to the second cycle of the study, which was the same as the first cycle.
Postprandial trial: 30 subjects are planned to be enrolled. According to the randomization table, each subject will be randomly assigned to one of the two groups. In cycle 1, after fasting for at least 10 h, all subjects will consume one high-fat, high-heat meal starting 30 ± 0.5 min prior to study drug administration, starting with the first subject in sequence and finishing before drug administration. One group of subjects received 2.5 mg of apixaban tablets and the other group received 2.5 mg of apixaban tablets , 7 days after crossover dosing, for the second cycle of the study.
- Conditions
- Healthy
- Being tested
- test apixaban tablets, reference apixaban tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test apixaban tabletsDrug
specification: 2.5 mg, manufacturer: Disha Pharmaceutical Group Co., Ltd., Shandong, China
reference apixaban tabletsDrug
specification: 2.5 mg, manufacturer: Bristol-Myers Squibb Manufacturing Company, USA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: test apixaban tablets; Drug: reference apixaban tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 48hours
Area under the plasma concentration versus time curve (AUC0-t)
Evaluation of Area under the plasma concentration versus time curve (AUC0-t)
Measured: 48hours
Area under the plasma concentration versus time curve (AUC0-∞)
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
Measured: 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start2 Mar 2021
- Primary completion17 Mar 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841446
- Sponsor's protocol ID
- DS-APSBBE-2020
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open, Randomized, Single-dose, Two-cycle, Two-sequence, Crossover Bioequivalence Study to Evaluate the Effects of the Test and the Fed States
- ClinicalTrials.gov ID
- NCT05841446
- Acronym / sponsor ID
- DS-APSBBE-2020
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Fasting test: 24 subjects were planned to be enrolled. Each subject was randomly assigned to one of the two groups according to a randomization table. In the first cycle, after fasting for at least 10 h, all subjects received the corresponding study drug orally in sequence starting with the first subject in the fasted state, with one group of subjects receiving the test preparation apixaban tablets 2.5 mg orally and the other group receiving the reference preparation apixaban tablets 2.5 mg orally, and then 7 days later crossed over to the second cycle of the study, which was the same as the first cycle.
Postprandial trial: 30 subjects are planned to be enrolled. According to the randomization table, each subject will be randomly assigned to one of the two groups. In cycle 1, after fasting for at least 10 h, all subjects will consume one high-fat, high-heat meal starting 30 ± 0.5 min prior to study drug administration, starting with the first subject in sequence and finishing before drug administration. One group of subjects received 2.5 mg of apixaban tablets and the other group received 2.5 mg of apixaban tablets , 7 days after crossover dosing, for the second cycle of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/reference | Experimental | Drug: test apixaban tablets, Drug: reference apixaban tabletsSubjects 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. |
| Reference/test | Experimental | Drug: test apixaban tablets, Drug: reference apixaban tabletsSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test apixaban tabletsspecification: 2.5 mg, manufacturer: Disha Pharmaceutical Group Co., Ltd., Shandong, China | Drug | Reference/test, Test/reference |
| reference apixaban tabletsspecification: 2.5 mg, manufacturer: Bristol-Myers Squibb Manufacturing Company, USA | Drug | Reference/test, Test/reference |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 48hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 48hours
Evaluation of Area under the plasma concentration versus time curve (AUC0-t)
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: 48hours
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing test apixaban tablets and reference apixaban tablets in people with Healthy, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 48hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.