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

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.

Study Overview

• Status: Unknown
• Conditions: Anticoagulant
• Intervention / Treatment: Drug: WD-1602; Drug: Pradaxa®

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: WD-1602; dabigatran etexilate mesylate granules for oral suspension
Active Comparator: 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.	Drug: Pradaxa®; dabigatran etexilate capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Cmax	the maximum concentration	pre-dose (baseline) and day 1, day 2, day 3 post-dose at designed time intervals.

Collaborators and Investigators

• Sponsor: Hong Kong WD Pharmaceutical Co., Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): January 6, 2021
• Primary Completion (Anticipated): June 6, 2021
• Study Completion (Anticipated): December 6, 2021

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran
• Other Study ID Numbers: WD-1602-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No