A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition
NCT ID: NCT04592822
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2021-01-06
2021-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment T
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.
WD-1602
dabigatran etexilate mesylate granules for oral suspension
Treatment R
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.
Pradaxa®
dabigatran etexilate capsules
Interventions
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WD-1602
dabigatran etexilate mesylate granules for oral suspension
Pradaxa®
dabigatran etexilate capsules
Eligibility Criteria
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Inclusion Criteria
2. 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.).
3. Body Mass Index (BMI) between 18.0 and 29.0 kg/m2, inclusive.
4. 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.
5. Willingness of male subjects to use barrier contraception (condom with spermicide) and refrain from donating sperm, for the duration of study participation.
6. Normal coagulation function (prothrombin time \[PT\] and partial thromboplastin time \[PTT\] \< 1.2 x upper limit of normal of normal \[ULN\] laboratory reference range).
7. Normal hepatic function (alanine aminotransferase \[ALT\] \< 1.2 × ULN; total bilirubin level \< 2 × ULN).
8. Normal renal function (estimated glomerular filtration rate \> 60 mL/min/1.73 m2).
9. 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.
Exclusion Criteria
2. Clinically significant surgery of gastrointestinal tract or evidence of significant gastrointestinal motility problems that could affect absorption of the drug.
3. Diseases of the central nervous system (included but not limited to any kind of seizures; stroke or psychiatric disorders).
4. 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.
5. History of significant orthostatic hypotension, fainting spells or blackouts.
6. Chronic or relevant acute infections.
7. 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)..
8. 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.
9. Alcohol abuse (more than 20 g/day).
10. Drug abuse.
11. Blood donation (more than 100 mL within four weeks prior to administration or during the trial);
12. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial.
13. Any laboratory value outside the reference range that is of clinical significance or positive drug or virus screening.
14. Planned surgeries within four weeks following the end-of study examination; and
15. Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding within days before or after end-of study examination.
18 Years
55 Years
ALL
Yes
Sponsors
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Hong Kong WD Pharmaceutical Co., Limited
INDUSTRY
Responsible Party
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Other Identifiers
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WD-1602-1001
Identifier Type: -
Identifier Source: org_study_id