MedTrace Logo

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

NCT06441916 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-06

No results posted yet for this study

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

Interventions

DRUG

Dabigatran Etexilate Capsules 150 mg

Dabigatran Etexilate

Sponsors & Collaborators

  • International Bio service

    lead NETWORK

Principal Investigators

  • Porranee Puranajoti, Ph. D · International Bio Service Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2024-10-08
Completion
2024-11-07

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06441916 on ClinicalTrials.gov