Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese SubjectsPhase 1NCT06876623
Bioequivalence Study of Two Dabigatran Etexilate Mesylate Capsules in Healthy Subjects
A Phase 1 study testing dabigatran etexilate mesylate capsules 150mg in people with Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
Trial summary
In recent years, novel oral anticoagulants (NOACs) such as Factor Xa inhibitors and direct thrombin inhibitors (e.g., dabigatran etexilate) have emerged. These agents target a single factor in the coagulation pathway and offer advantages including rapid onset of action, fixed dosing, no requirement for coagulation… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects
- What is being tested?
- dabigatran etexilate mesylate capsules 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2019to 12 Jun 2020
- 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
- Healthy male or female subjects over 18 years old ( including 18 years old ) ;
- Weight index in the range of 19.0 ~ 26.0 kg / m2 ( including the critical value
- male weight is not less than 50 kg, female weight is not less than 45 kg ;
- Subjects fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as subjects, and sign informed consent.
Who cannot join
- The researchers determined that the clinical significance of the cardiovascular system, respiratory system, digestive system, urinary system, endocrine system ;
- Subjects with clinically significant abnormalities in physical examination, vital signs, laboratory tests ( creatinine clearance < 80 mL / min ), 12-lead electrocardiogram ( ECG ), or chest X-ray ( posteroanterior and lateral views ) as deemed by the investigator ;
- Positive results for any of the hepatitis B surface antigen ( HBsAg ), hepatitis B e antigen ( HBeAg ), hepatitis C virus ( HCV ) antibody, human immunodeficiency virus ( HIV ) antibody, or treponema pallidum antibody (TP-Ab) ;
- The investigators determined a history of clinically significant food, drug allergies or other allergic diseases ( asthma, urticaria, eczema dermatitis, etc. ) or any excipients or similar drugs in dabigatran etexilate mesylate capsules have a history of allergy ;
- Subjects with coagulopathy, bleeding tendency ( e.g., recurrent gingival bleeding ), history of bleeding events associated with increased risk within the past 6 months, prior intracranial hemorrhage, gastrointestinal bleeding, purpura, active pathological bleeding, or history of intracranial hemorrhage ;
- Women with a previous history of dysfunctional uterine bleeding, including excessive menstrual bleeding, irregular uterine bleeding, or prolonged menstrual cycles ( length of period > 7 days ) ;
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- Patients who underwent surgery within 4 weeks before screening ;
- Those who had a history of drug abuse within 12 months before screening or were positive in urine screening test ;
- Positive alcohol breath test results, or previous alcohol abuse in the past 3 months ( more than 14 units of alcohol per week : 1 unit = beer about 285mL, or spirits about 25mL, or wine about 100mL ), or can not guarantee the test period abandoned drinkers ;
- Patients who drank excessive tea, coffee or caffeine-containing beverages for a long time in the past 3 months ( more than 8 cups a day, 1 cup = 250 mL ), or who drank tea, coffee and / or caffeine-containing beverages within 48 hours before the first administration ;
- Those who have special requirements for diet and cannot comply with a unified diet ( such as intolerance to standard meals, intolerance to lactose, etc. ) or who have difficulty in swallowing, or can not avoid eating grapefruit, grapefruit, mango and other fruits or juices that may affect metabolism ;
- Smokers in the past 3 months ( daily smoking ≥ 5 ) or can not guarantee to give up smoking during the trial ;
- Any prescription drugs, non-prescription drugs, and Chinese herbal medicines were used within 14 days before screening ;
- Anyone who has used any drug that interacts with dabigatran mesylate capsules ( e.g., anticoagulants and antiplatelet aggregating agents, P-gp inhibitors, P-gp inducers, P-gp substrates, other medications affecting P-gp, medications affecting intragastric pH ) in the 4 weeks prior to screening ;
- Those who have participated in a clinical trial of another drug within 3 months prior to screening ( last visit of the previous trial is calculated as the start time ) ;
- Those who have donated ≥ 400mL or 2 units of blood or blood products within 3 months prior to screening or those who have lost ≥ 400mL of blood within 6 months ( except for physiologic blood loss in women ) ;
- Pregnant or breastfeeding women or female subjects who are not using effective contraception within 1 month prior to screening, male subjects ( or their partners ) or female subjects who are planning to become pregnant from the time of signing the informed consent form until 6 months after the last dose, sperm donors or those who are planning to donate eggs, and those who do not wish to use effective contraception during the trial period and for 6 months after the last dose ;
- Those who do not agree to avoid strenuous exercise for 48 hours prior to trial administration ;
- Those who have difficulty in collecting blood intravenously or who suffer from needle and blood sickness ;
- Subjects who, in the opinion of the investigator, are not suitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Trials Center, The Affiliated Hospital of Guizhou Medical University
Guiyang
About this study
Official title: A Single-dose, Two-sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Dabigatran Etexilate Mesylate Capsules in Healthy Subjects Under Fasting and Fed Conditions
In recent years, novel oral anticoagulants (NOACs) such as Factor Xa inhibitors and direct thrombin inhibitors (e.g., dabigatran etexilate) have emerged. These agents target a single factor in the coagulation pathway and offer advantages including rapid onset of action, fixed dosing, no requirement for coagulation monitoring, and fewer interactions with food and other drugs. Their efficacy and safety in patients with non-valvular atrial fibrillation (NVAF) have been validated by large-scale clinical trials.
The aim of this study was to evaluate the bioequivalence of dabigatran mesylate capsules from two different manufacturers after administration to healthy subjects in fasting and postprandial states and to observe the safety of the test and the reference formulation in healthy subjects.
- Being tested
- dabigatran etexilate mesylate capsules 150mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabigatran etexilate mesylate capsules 150mgDrug
Oral dabigatran etexilate mesylate capsules，150mg Once every seven days，two cycle T drug, two cycles R drug
| Study group | Role | What they receive |
|---|---|---|
| Fasting TRTR group | Experimental | Not described Receives: Drug: dabigatran etexilate mesylate capsules 150mg |
| Fasting RTRT group | Experimental | Not described Receives: Drug: dabigatran etexilate mesylate capsules 150mg |
| Postprandial TRTR group | Experimental | Not described Receives: Drug: dabigatran etexilate mesylate capsules 150mg |
| Postprandial RTRT group | Experimental | Not described Receives: Drug: dabigatran etexilate mesylate capsules 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum observed serum or plasma concentration
The with-subject standard deviation of the pharmacokinetic parameter Cmax of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
Measured: 2 day
area under the serum or plasma concentration-time curve from 0 to t
The with-subject standard deviation of the pharmacokinetic parameter AUC0-t of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
Measured: 2 day
area under the serum or plasma concentration-time curve from 0 to infinity
The with-subject standard deviation of the pharmacokinetic parameter AUC0-inf of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start10 Dec 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese SubjectsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876623
- Sponsor's protocol ID
- YG-18007-BE
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Two-sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Dabigatran Etexilate Mesylate Capsules in Healthy Subjects Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT06876623
- Acronym / sponsor ID
- YG-18007-BE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 14 Mar 2025 (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.
In recent years, novel oral anticoagulants (NOACs) such as Factor Xa inhibitors and direct thrombin inhibitors (e.g., dabigatran etexilate) have emerged. These agents target a single factor in the coagulation pathway and offer advantages including rapid onset of action, fixed dosing, no requirement for coagulation monitoring, and fewer interactions with food and other drugs. Their efficacy and safety in patients with non-valvular atrial fibrillation (NVAF) have been validated by large-scale clinical trials.
The aim of this study was to evaluate the bioequivalence of dabigatran mesylate capsules from two different manufacturers after administration to healthy subjects in fasting and postprandial states and to observe the safety of the test and the reference formulation in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fasting TRTR group | Experimental | Drug: dabigatran etexilate mesylate capsules 150mg |
| Fasting RTRT group | Experimental | Drug: dabigatran etexilate mesylate capsules 150mg |
| Postprandial TRTR group | Experimental | Drug: dabigatran etexilate mesylate capsules 150mg |
| Postprandial RTRT group | Experimental | Drug: dabigatran etexilate mesylate capsules 150mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects over 18 years old ( including 18 years old ) ;
- Weight index in the range of 19.0 ~ 26.0 kg / m2 ( including the critical value
- Subjects fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as subjects, and sign informed consent.
Key exclusion criteria (20 listed)
- The researchers determined that the clinical significance of the cardiovascular system, respiratory system, digestive system, urinary system, endocrine system ;
- Subjects with clinically significant abnormalities in physical examination, vital signs, laboratory tests ( creatinine clearance < 80 mL / min ), 12-lead electrocardiogram ( ECG ), or chest X-ray ( posteroanterior and lateral views ) as deemed by the investigator ;
- Positive results for any of the hepatitis B surface antigen ( HBsAg ), hepatitis B e antigen ( HBeAg ), hepatitis C virus ( HCV ) antibody, human immunodeficiency virus ( HIV ) antibody, or treponema pallidum antibody (TP-Ab) ;
- The investigators determined a history of clinically significant food, drug allergies or other allergic diseases ( asthma, urticaria, eczema dermatitis, etc. ) or any excipients or similar drugs in dabigatran etexilate mesylate capsules have a history of allergy ;
- Subjects with coagulopathy, bleeding tendency ( e.g., recurrent gingival bleeding ), history of bleeding events associated with increased risk within the past 6 months, prior intracranial hemorrhage, gastrointestinal bleeding, purpura, active pathological bleeding, or history of intracranial hemorrhage ;
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 |
|---|---|---|
| dabigatran etexilate mesylate capsules 150mgOral dabigatran etexilate mesylate capsules，150mg Once every seven days，two cycle T drug, two cycles R drug | Drug | Fasting RTRT group, Fasting TRTR group, Postprandial RTRT group, Postprandial TRTR group |
Primary outcome
maximum observed serum or plasma concentration
Time frame: 2 day
The with-subject standard deviation of the pharmacokinetic parameter Cmax of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
area under the serum or plasma concentration-time curve from 0 to t
Time frame: 2 day
The with-subject standard deviation of the pharmacokinetic parameter AUC0-t of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
area under the serum or plasma concentration-time curve from 0 to infinity
Time frame: 2 day
The with-subject standard deviation of the pharmacokinetic parameter AUC0-inf of the reference preparation was calculated and the bioequivalence was analyzed according to the bioequivalence evaluation criteria.
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 29 Jun 2025.
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 dabigatran etexilate mesylate capsules 150mg in people with Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects, run by The Affiliated Hospital Of Guizhou Medical 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 4 inclusion and 20 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 29 Jun 2025. 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?
maximum observed serum or plasma concentration (time frame: 2 day). 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 29 Jun 2025.