Healthy VolunteerPhase 1NCT06441916
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
A Phase 1 study testing Dabigatran Etexilate Capsules 150 mg in people with Healthy Volunteer and Dabigatran, run by International Bio service.
Trial summary
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of free dabigatran and total dabigatran. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Dabigatran, Bioequivalence Study
- What is being tested?
- Dabigatran Etexilate Capsules 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2024to 7 Nov 2024
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period 1.
- Body mass index between 18.5 to 30.0 kg/m2
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study
- Non-smoker and non-consumer of nicotine containing products. Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked/consumed or stopped for at least 90 days.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
- Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 4. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
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- Postmenopausal for at least 1 year or
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
- Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 4.
- Able to understand and voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
- Adequate venous access in both arms for the collection of a number of samples during the study.
Who cannot join
- History of hypersensitivity to dabigatran or dabigatran etexilate or to any of the excipients of product
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19.
- History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
- Have eGFR (CKD-EPI) < 50 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment.
- History or evidence of haemorrhagic manifestations, patients with a bleeding diathesis or patients with spontaneous or pharmacological impairment of haemostasis.
- History or evidence of organ lesions at risk of clinically significant bleeding, including haemorrhagic stroke within the last 6 months.
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- History or evidence of surgery for prosthetic heart valve replacement.
- History or evidence of surgery for knee or hip replacement.
- History or evidence of venous thromboembolic events, deep vein thrombosis or pulmonary embolism.
- History or evidence of stroke.
- History or evidence of atrial fibrillation.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy.
- History of diarrhea or vomiting within 24 hours prior to check-in in each period.
- History of problems with swallowing tablet or capsule.
- History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine).
- 12-lead ECG demonstrating QTc > 450 msec, a QRS interval > 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
- Investigation with blood sample shows positive test for HBsAg.
- Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.).
- History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in and continued for entire duration of the study or alcohol breath test shows positive result In case of alcohol breath test result represents the alcohol concentration range of
- 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject's eligibility which must be 0 mg%BAC.
- History or evidence of habitual consume of any caffeine- or xanthine-containing products e.g. tea, coffee, chocolate, colas etc. and cannot abstain for at least 72 hours prior to check-in and continued for entire duration of the study.
- Consume or drink juice of grapefruit or orange or pomelo or its supplement/ containing products and cannot abstain for at least 7 days prior to check-in and continued for entire duration of the study.
- Use of prescription or nonprescription drugs (e.g. paracetamol, amiodarone, verapamil, quinidine, ketoconazole, dronedarone, ticagrelor, clarithromycin, other anticoagulants, NSAIDs, selective serotonin reuptake inhibitors, selective serotonin norepinephrine reuptake inhibitors, fibrinolytic agents and etc.), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to check-in in Period 1 and continued for entire duration of the study
- Participated in other clinical trials within 90 days prior to check-in in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study
- Blood donation or blood loss ≥ 1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to check-in in Period 1 or during enrollment.
- Subjects with poor venous access or intolerant to venipuncture.
- Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study.
- Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Dabigatran Etexilate Capsules 150 mg and Reference Product (Pradaxa®) in Healthy Thai Volunteers Under Fasting Conditions and Under Pre-treatment With a Proton Pump Inhibitor
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of free dabigatran and total dabigatran.
Read the detailed description
Bioequivalence study is a research study that needs to compare the rate and extent to which the active substance or active moiety is absorbed from a pharmaceutical dosage form between innovator or reference product and test product when given in healthy subjects at the same dose and strength. The acceptance criteria in bioequivalence study will be done by comparing the pharmacokinetic parameters including maximal plasma concentration (Cmax) time at which the maximum plasma concentration occurs (Tmax) and area under the plasma concentration curve (AUC) either area under the plasma concentration curve from administration to last observed concentration at time t (AUC0-tlast) or area under the plasma concentration curve extrapolated to infinite time (AUC0-∞). Those parameters should be calculated only from the plasma concentration and time curve but cannot use other data obtained from in vitro study. By this reason, it is necessary to conduct the study in healthy subjects
- Conditions
- Healthy Volunteer, Dabigatran, Bioequivalence Study
- Being tested
- Dabigatran Etexilate Capsules 150 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran Etexilate Capsules 150 mgDrug
Also called Dabigatran
Dabigatran Etexilate
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran Etexilate Capsules 150 mg | Experimental | Each capsule contains Dabigatran Etexilate 150 mg Receives: Drug: Dabigatran Etexilate Capsules 150 mg |
| Pradaxa® | Active comparator | Dabigatran Etexilate Receives: Drug: Dabigatran Etexilate Capsules 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of Dabigatran
Maximum measured plasma concentration over the time span specified.
Measured: Through 48 Hours Post Dose
Plasma Area Under the Curve AUC(0 to 48hr, AUC0-∞
The area under the plasma concentration versus time curve.
Measured: Through 48 Hours Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start25 Sep 2024 (estimated)
- Primary completion8 Oct 2024 (estimated)
- Study completion7 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Bio service
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Porranee Puranajoti, Ph. D, Principal investigator, International Bio Service Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441916
- Sponsor's protocol ID
- BE24-008
- Status last verified
- Apr 2024
- First submitted
- 26 May 2024
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Dabigatran Etexilate Capsules 150 mg and Reference Product (Pradaxa®) in Healthy Thai Volunteers Under Fasting Conditions and Under Pre-treatment With a Proton Pump Inhibitor
- ClinicalTrials.gov ID
- NCT06441916
- Acronym / sponsor ID
- BE24-008
- Conditions
- Healthy Volunteer, Dabigatran, Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- International Bio serviceResearch network
- Study start
- 25 Sep 2024 (estimated)
- Primary completion
- 8 Oct 2024 (estimated)
- Study completion
- 7 Nov 2024 (estimated)
- First posted
- 4 Jun 2024 (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.
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of free dabigatran and total dabigatran.
Detailed description
Bioequivalence study is a research study that needs to compare the rate and extent to which the active substance or active moiety is absorbed from a pharmaceutical dosage form between innovator or reference product and test product when given in healthy subjects at the same dose and strength. The acceptance criteria in bioequivalence study will be done by comparing the pharmacokinetic parameters including maximal plasma concentration (Cmax) time at which the maximum plasma concentration occurs (Tmax) and area under the plasma concentration curve (AUC) either area under the plasma concentration curve from administration to last observed concentration at time t (AUC0-tlast) or area under the plasma concentration curve extrapolated to infinite time (AUC0-∞). Those parameters should be calculated only from the plasma concentration and time curve but cannot use other data obtained from in vitro study. By this reason, it is necessary to conduct the study in healthy subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran Etexilate Capsules 150 mg | Experimental | Drug: Dabigatran Etexilate Capsules 150 mgEach capsule contains Dabigatran Etexilate 150 mg |
| Pradaxa® | Active comparator | Drug: Dabigatran Etexilate Capsules 150 mgDabigatran Etexilate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period 1.
- Body mass index between 18.5 to 30.0 kg/m2
- Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study
- Non-smoker and non-consumer of nicotine containing products. Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked/consumed or stopped for at least 90 days.
- Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
Key exclusion criteria (29 listed)
- History of hypersensitivity to dabigatran or dabigatran etexilate or to any of the excipients of product
- History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19.
- History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
- Have eGFR (CKD-EPI) < 50 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment.
- History or evidence of haemorrhagic manifestations, patients with a bleeding diathesis or patients with spontaneous or pharmacological impairment of haemostasis.
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 Capsules 150 mgAlso: DabigatranDabigatran Etexilate | Drug | Dabigatran Etexilate Capsules 150 mg, Pradaxa® |
Primary outcome
Peak Plasma Concentration (Cmax) of Dabigatran
Time frame: Through 48 Hours Post Dose
Maximum measured plasma concentration over the time span specified.
Plasma Area Under the Curve AUC(0 to 48hr, AUC0-∞
Time frame: Through 48 Hours Post Dose
The area under the plasma concentration versus time curve.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
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Screening Protocol
Pain
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.
Porranee Puranajoti, Ph. D principal investigator
International Bio Service Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dabigatran Etexilate Capsules 150 mg in people with Healthy Volunteer and Dabigatran, run by International Bio service.
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 11 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanaporn Wongyai, M.Sc.Pharm (024415211 ext. 220, thanaporn.won@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of Dabigatran (time frame: Through 48 Hours Post Dose). The study lists 2 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 6 Jun 2024.