Recruiting

DW-1021Pelubiprofen-Tramadol Combination Tablets Pharmacokinetic Study in Healthy Vietnamese Men

Study Aim

This study observes how Pelubiprofen-Tramadol tablets affect drug absorption in healthy Vietnamese men, helping ensure safe and effective use of this medication.

What is being tested

DW-1021

+ Pelubi CR + Zytram CR

Drug

Who is being recruted

From 18 to 45 Years

+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorHaiphong University of Medicine and Pharmacy

Study ContactNguyen Thi Thu Phuong, MD, PhD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 20, 2025

Actual date on which the first participant was enrolled.

This study is investigating how a combination drug called DW-1021, which includes Pelubiprofen and Tramadol, is processed by the body compared to taking Pelubiprofen and Tramadol separately. This research involves healthy adult Vietnamese men and takes place under fasting conditions. Understanding how these drugs are absorbed and processed can help improve pain management treatments by potentially offering a more effective or convenient dosing option. Participants in this trial will take either the combination drug or the separate drugs in a controlled sequence, with a period of time in between each dosing to allow the body to clear the drugs. Blood samples are collected up to 48 hours after taking the medication to measure drug levels in the body. The study closely monitors safety by checking for any side effects and changes in health through various assessments. This research is conducted by Haiphong University of Medicine and Pharmacy and involves several checks and approvals to ensure ethical standards are met.

Official TitleA Randomized, Open-label, Single Oral Dose, Two-period, Cross-over Trial to Evaluate the Pharmacokinetics of Pelubiprofen-Tramadol (DW-1021) Controlled Release Film Coated Tablets (Pelubiprofen 45mg-Tramadol 45.9mg Salt) (Test Drug) in Comparison With the Co-administration of Each of Pelubi CR 45mg Controlled Release Film Coated Tablets (Pelubiprofen 45mg) and Zytram CR 75mg Controlled Release Film Coated Tablets (Tramadol HCl 75mg) in Healthy Adult Vietnamese Male Subjects Under Fasting Condition

NCT07032558

Principal SponsorHaiphong University of Medicine and Pharmacy

Study ContactNguyen Thi Thu Phuong, MD, PhD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate

Healthy male subjects aged 20 to 40 years at screening visit

Body Mass Index (BMI) between 18.5 and 24.9 kg/m²

Body weight greater than 50 kg

Systolic blood pressure between 100 mmHg and 129 mmHg; diastolic blood pressure less than 84 mmHg

Show More Criteria

8 exclusion criteria prevent from participating

Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to administration, or use of any medication that might affect the study within 10 days prior to administration

Participation in any other clinical trial within 3 months prior to screening

Blood donation within 8 weeks prior to drug administration

History of gastrointestinal surgery that may affect drug absorption

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants in this arm will receive the test drug DW-1021 (Pelubiprofen 45 mg - Tramadol 45.9 mg salt) in Period I, followed by the reference drugs-Pelubi CR 45 mg and Zytram CR 75 mg-in Period II. A 14-day washout period separates the two dosing periods.

Group II

Active Comparator

Participants in this arm will receive the reference drugs-Pelubi CR 45 mg and Zytram CR 75 mg-in Period I, followed by the test drug DW-1021 (Pelubiprofen 45 mg - Tramadol 45.9 mg salt) in Period II. A 14-day washout period separates the two dosing periods.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Clinical Trial and Bioequivalence Center

Haiphong, VietnamOpen Clinical Trial and Bioequivalence Center in Google Maps

Recruiting soon

Clinical Trial and Bioequivalence Center

Haiphong, Vietnam

Recruiting

2 Study Centers