AnticoagulantPhase 1NCT04592822
A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition
A Phase 1 study testing WD-1602 and Pradaxa® in people with Anticoagulant, run by Hong Kong WD Pharmaceutical Co., Limited.
Trial summary
This study will be a single-center, randomized, single-dose, open-label, two-treatment, two-period, two-sequence crossover bioequivalence study to compare the rate and extent of absorption of WD-1602 granule formulation (WD Pharma) to the reference drug Pradaxa® capsule (BI, Germany) under fed conditions in healthy… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anticoagulant
- What is being tested?
- WD-1602 and Pradaxa®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2021to 6 Dec 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead; electrocardiogram (ECG), clinical laboratory tests.
- Ages of 18 and 55 years, inclusive, who have a minimum body weight of 50.0 kg (110.0 lbs.) and ≤ 100 kg (220 lbs.).
- Body Mass Index (BMI) between 18.0 and 29.0 kg/m2, inclusive.
- Negative urine pregnancy test in women of childbearing potential who are not actively breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control (abstinence from heterosexual activity that could result in conception, hormonal contraceptives, condom with spermicide, diaphragm or cervical cap with spermicide, or intrauterine device) for the duration of study participation; or women of nonchildbearing potential who are > 1 year postmenopausal with follicle-stimulating hormone in the postmenopausal range.
- Willingness of male subjects to use barrier contraception (condom with spermicide) and refrain from donating sperm, for the duration of study participation.
- Normal coagulation function (prothrombin time [PT] and partial thromboplastin time [PTT] < 1.2 x upper limit of normal of normal [ULN] laboratory reference range).
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- Normal hepatic function (alanine aminotransferase [ALT] < 1.2 × ULN; total bilirubin level < 2 × ULN).
- Normal renal function (estimated glomerular filtration rate > 60 mL/min/1.73 m2).
- Ability to understand informed consent, which must be signed before any study-related procedures are performed in accordance with Good Clinical Practice (GCP) and the local legislation.
Who cannot join
- Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Clinically significant surgery of gastrointestinal tract or evidence of significant gastrointestinal motility problems that could affect absorption of the drug.
- Diseases of the central nervous system (included but not limited to any kind of seizures; stroke or psychiatric disorders).
- Any history or evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies.
- History of significant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections.
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- History of allergy/hypersensitivity (including drug allergy in particular to study drug or its excipients) which is deemed relevant to the trial as judged by the Principal Investigator (i.e., an Ontario-licensed physician) or Sub-Investigator (Ontario-licensed physician and/or Nurse Practitioner)..
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial.
- Alcohol abuse (more than 20 g/day).
- Drug abuse.
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial);
- Participation in another trial with an investigational drug within four weeks prior to administration or during the trial.
- Any laboratory value outside the reference range that is of clinical significance or positive drug or virus screening.
- Planned surgeries within four weeks following the end-of study examination; and
- Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding within days before or after end-of study examination.
About this study
Official title: A Single Dose, Randomized, Open Label, Two-Treatment, Two-Sequence, Two-Period, Crossover Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition
This study will be a single-center, randomized, single-dose, open-label, two-treatment, two-period, two-sequence crossover bioequivalence study to compare the rate and extent of absorption of WD-1602 granule formulation (WD Pharma) to the reference drug Pradaxa® capsule (BI, Germany) under fed conditions in healthy subjects.
Read the detailed description
The study will comprise of a medical Screening visit, two 2-night (3-day) Treatment Periods, 2 outpatient visits, and a Follow-up visit. Each Treatment visit will be separated by a washout of up to 7 days. The Follow-up visit will occur approximately 7 days (±1) following the last study drug administration. The duration of subject participation, including screening, will be approximately 8 weeks.
- Conditions
- Anticoagulant
- Being tested
- WD-1602, Pradaxa®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WD-1602Drug
dabigatran etexilate mesylate granules for oral suspension
Pradaxa®Drug
dabigatran etexilate capsules
| Study group | Role | What they receive |
|---|---|---|
| Treatment T | Experimental | 30 minutes after the start of a standard breakfast, subjects will take one straw of WD-1602 Dabigatran Etexilate Mesylate Granules (150 mg) in 100 mL water as oral administration. Receives: Drug: WD-1602 |
| Treatment R | Active comparator | 30 minutes after the start of a standard breakfast, subjects will receive a single Pradaxa® 150 mg capsule swallowed with 240 mL water as oral administration. Receives: Drug: Pradaxa® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
area under the plasma concentration-time curve from time 0 to time t
Measured: pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.
AUC0-inf
area under the concentration-time curve from time 0 to time infinity
Measured: pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.
Cmax
the maximum concentration
Measured: pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start6 Jan 2021 (estimated)
- Primary completion6 Jun 2021 (estimated)
- Study completion6 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong WD Pharmaceutical Co., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592822
- Sponsor's protocol ID
- WD-1602-1001
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open Label, Two-Treatment, Two-Sequence, Two-Period, Crossover Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition
- ClinicalTrials.gov ID
- NCT04592822
- Acronym / sponsor ID
- WD-1602-1001
- Conditions
- Anticoagulant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hong Kong WD Pharmaceutical Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2021 (estimated)
- Primary completion
- 6 Jun 2021 (estimated)
- Study completion
- 6 Dec 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
This study will be a single-center, randomized, single-dose, open-label, two-treatment, two-period, two-sequence crossover bioequivalence study to compare the rate and extent of absorption of WD-1602 granule formulation (WD Pharma) to the reference drug Pradaxa® capsule (BI, Germany) under fed conditions in healthy subjects.
Detailed description
The study will comprise of a medical Screening visit, two 2-night (3-day) Treatment Periods, 2 outpatient visits, and a Follow-up visit. Each Treatment visit will be separated by a washout of up to 7 days. The Follow-up visit will occur approximately 7 days (±1) following the last study drug administration. The duration of subject participation, including screening, will be approximately 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment T | Experimental | Drug: WD-160230 minutes after the start of a standard breakfast, subjects will take one straw of WD-1602 Dabigatran Etexilate Mesylate Granules (150 mg) in 100 mL water as oral administration. |
| Treatment R | Active comparator | Drug: Pradaxa®30 minutes after the start of a standard breakfast, subjects will receive a single Pradaxa® 150 mg capsule swallowed with 240 mL water as oral administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy males and females according to the following criteria: based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead; electrocardiogram (ECG), clinical laboratory tests.
- Ages of 18 and 55 years, inclusive, who have a minimum body weight of 50.0 kg (110.0 lbs.) and ≤ 100 kg (220 lbs.).
- Body Mass Index (BMI) between 18.0 and 29.0 kg/m2, inclusive.
- Negative urine pregnancy test in women of childbearing potential who are not actively breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control (abstinence from heterosexual activity that could result in conception, hormonal contraceptives, condom with spermicide, diaphragm or cervical cap with spermicide, or intrauterine device) for the duration of study participation; or women of nonchildbearing potential who are > 1 year postmenopausal with follicle-stimulating hormone in the postmenopausal range.
- Willingness of male subjects to use barrier contraception (condom with spermicide) and refrain from donating sperm, for the duration of study participation.
Key exclusion criteria (15 listed)
- Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Clinically significant surgery of gastrointestinal tract or evidence of significant gastrointestinal motility problems that could affect absorption of the drug.
- Diseases of the central nervous system (included but not limited to any kind of seizures; stroke or psychiatric disorders).
- Any history or evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies.
- History of significant orthostatic hypotension, fainting spells or blackouts.
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 |
|---|---|---|
| WD-1602dabigatran etexilate mesylate granules for oral suspension | Drug | Treatment T |
| Pradaxa®dabigatran etexilate capsules | Drug | Treatment R |
Primary outcome
AUC0-t
Time frame: pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.
area under the plasma concentration-time curve from time 0 to time t
AUC0-inf
Time frame: pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.
area under the concentration-time curve from time 0 to time infinity
Cmax
Time frame: pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.
the maximum concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WD-1602 and Pradaxa® in people with Anticoagulant, run by Hong Kong WD Pharmaceutical Co., Limited.
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 9 inclusion and 15 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 2 Nov 2020. 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?
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?
AUC0-t (time frame: pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.). 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 2 Nov 2020.