A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition

Anticoagulant Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04592822
• Other study ID #: WD-1602-1001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 6, 2021
• Est. completion date: December 6, 2021

Study information

• Verified date: October 2020
• Source: Hong Kong WD Pharmaceutical Co., Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 subjects.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 6, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. 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.

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:

1. Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.

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.

Related Conditions & MeSH terms

• Anticoagulant
• Malnutrition

Intervention

Drug:
• WD-1602
dabigatran etexilate mesylate granules for oral suspension
• Pradaxa®
dabigatran etexilate capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong WD Pharmaceutical Co., Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	area under the plasma concentration-time curve from time 0 to time t	pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.
Primary	AUC0-inf	area under the concentration-time curve from time 0 to time infinity	pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.
Primary	Cmax	the maximum concentration	pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.