Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions

NCT06441916 | Not Yet Recruiting Phase 1

• 1 other identifier: BE24-008
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteer; Dabigatran; Bioequivalence Study

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax) of Dabigatran

  Maximum measured plasma concentration over the time span specified.

  Through 48 Hours Post Dose

• Plasma Area Under the Curve AUC(0 to 48hr, AUC0-∞

  The area under the plasma concentration versus time curve.

  Through 48 Hours Post Dose

Study Arms (2)

Dabigatran Etexilate Capsules 150 mg

EXPERIMENTAL

Each capsule contains Dabigatran Etexilate 150 mg

Drug: Dabigatran Etexilate Capsules 150 mg

Pradaxa®

ACTIVE COMPARATOR

Dabigatran Etexilate

Drug: Dabigatran Etexilate Capsules 150 mg

Interventions

Dabigatran Etexilate Capsules 150 mg DRUG

Dabigatran Etexilate

Also known as: Dabigatran

Dabigatran Etexilate Capsules 150 mg; Pradaxa®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• International Bio service: lead

MeSH Terms

Interventions

Dabigatran

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Porranee Puranajoti, Ph. D

  International Bio Service Co., Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanaporn Wongyai, M.Sc.Pharm

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Paweena Boonprakong, B.Sc.

CONTACT

024415211; paweena.bon@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 4, 2024
• Study Start: September 25, 2024
• Primary Completion: October 8, 2024
• Study Completion: November 7, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-04