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New treatment option for Healthy Volunteer
Official title Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions
ClinicalTrials.gov ID: NCT07032558
What this study is testing
What is DW-1021?
DW-1021 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteer.
Also referred to as Pelubiprofen 45 mg - Tramadol 45.9 mg salt combination, Pelubiprofen-Tramadol fixed-dose combination.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1, randomized, open-label, single-dose, two-period, cross-over study to evaluate the pharmacokinetics (PK) of DW-1021, a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), in healthy adult Vietnamese male volunteers. The study compares DW-1021 with the co-administration of two reference drugs: Pelubi CR 45 mg (Pelubiprofen) and Zytram CR 75 mg (Tramadol HCl), under fasting conditions.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, men only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male people 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
- Regular heart rate ranging from 60 to 90 beats per minute
You likely can't join if
- Use of drugs that induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to administration, or use of any medication...
- 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
- History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation
- Known hypersensitivity or allergy to the test or reference drug or their components
See the full eligibility criteria
- Healthy male people 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
- Regular heart rate ranging from 60 to 90 beats per minute
- No clinically significant medical history or evidence of congenital or chronic diseases, including but not limited to: hypertension, orthostatic hypotension, hypoglycemia when fasting, swallowing difficulties, diabetes...
- Suitable laboratory test results (hematology, urinalysis, blood chemistry, HCV/AIDS, HBsAg, anti-HCV) and electrocardiogram (ECG) at screening: no pathological findings; clinical laboratory parameters within the normal...
- Willing and able to provide written informed consent after being fully informed about the study objectives and possible adverse effects
- Agree to use effective contraception from initial administration until 7 days after the last dose of test or reference drugs
- 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
- History of drug abuse, or use of alcohol, drugs, or tobacco products within 1 year before participation
- Known hypersensitivity or allergy to the test or reference drug or their components
- Known genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, which are characterized by symptoms like diarrhea and bloating after consuming dairy products
- Suffering from dysphagia
The study team makes the final eligibility decision.
Where it's taking place
- Haiphong, Hai Phong, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haiphong, Hai Phong, Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.