Healthy VolunteerPhase 1DW-1021NCT07032558

Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions

A Phase 1 study testing DW-1021 and Pelubi CR + Zytram CR in people with Healthy Volunteer, run by Haiphong University of Medicine and Pharmacy at 2 sites in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: DW-1021 and Pelubi CR + Zytram CR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 2 sitesVietnam
Study dates: 20 Sep 2025to 25 Oct 2025
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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
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, cardiovascular diseases, pulmonary diseases, gastrointestinal diseases, liver insufficiency, renal insufficiency, endocrine disorders, neurological or psychiatric disorders, immunological, hematological, or hereditary diseases, tuberculosis, or infectious diseases

Show all 9Show fewer

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 range or, if outside the normal range, not clinically significant as judged by the investigator
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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nguyen Thi Thu Phuong, MD, PhD contact

+84936685007

nttphuong@hpmu.edu.vn

Vietnam2 sites, 2 recruiting

Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, 180000
Van Anh Tran, MSc.Pharm, 0343035492, tvanh@hpmu.edu.vn
Phuong Thi Thu Nguyen, MD, PhD, +84-0936685007, nttphuong@hpmu.edu.vn
Not yet recruiting
Clinical Trial and Bioequivalence Center
Haiphong, Hai Phong, 180000
Van Anh Tran, MSc.Pharm, 0343035492, tvanh@hpmu.edu.vn
Phuong Thi Thu Nguyen, MD, PhD, nttphuong@hpmu.edu.vn
Recruiting

Other trials in Vietnam

About this study

Official title: A 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

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.

A total of 14 eligible participants will be randomly assigned to receive either the test drug followed by the reference drugs, or vice versa, with a 14-day washout period between the two dosing periods. Blood samples will be collected over a 48-hour period after each administration to evaluate drug concentrations. The main purpose is to assess and compare the rate and extent of absorption (Cmax, AUC) of the test and reference products.

The study is sponsored by Haiphong University of Medicine and Pharmacy in collaboration with Daewon Pharmaceutical Co., Ltd. It is conducted under ethical approval by the National Ethics Committee in Biomedical Research of Vietnam.

Read the detailed description

This clinical trial is designed to evaluate and compare the pharmacokinetic characteristics of DW-1021, a fixed-dose combination of Pelubiprofen and Tramadol in salt form (Pelubiprofen 45 mg - Tramadol 45.9 mg), with the co-administration of the individual components-Pelubi CR 45 mg (controlled release Pelubiprofen) and Zytram CR 75 mg (controlled release Tramadol hydrochloride)-in healthy adult male Vietnamese volunteers under fasting conditions.

This is an open-label, randomized, single-dose, two-treatment, two-period, two-sequence crossover study. Fourteen eligible participants will be randomized into two sequences: Test-Reference (TR) and Reference-Test (RT), with each dosing period separated by a 14-day washout. Study drugs will be administered in a fasted state, and blood samples will be collected at multiple time points up to 48 hours post-dose for pharmacokinetic analysis.

The primary PK parameters include Cmax and AUCt. Secondary PK parameters include Tmax, AUC∞, and t1/2. Safety will be monitored through assessment of adverse events, vital signs, clinical laboratory tests, and physical examinations throughout the study.

The trial is sponsored by Haiphong University of Medicine and Pharmacy. Analytical testing of plasma concentrations will be performed by Invites Bio-Core, and CRO support is provided by Big Leap Clinical Research Support JSC. The study is approved by the National Ethics Committee in Biomedical Research of Vietnam (Approval No. 277/CN-HĐĐĐ, dated 12/12/2024). This study was additionally approved for protocol amendments by the Vietnamese Ministry of Health under Decision No. 3840/QĐ-BYT, dated December 19, 2024.

Conditions: Healthy Volunteer
Being tested: DW-1021, Pelubi CR + Zytram CR
Keywords: Pelubiprofen, Tramadol, DW-1021, Pharmacokinetics, Fixed-Dose Combination, Bioavailability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DW-1021Drug
Also called Pelubiprofen 45 mg - Tramadol 45.9 mg salt combination, Pelubiprofen-Tramadol fixed-dose combination
DW-1021 is a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), formulated as a controlled-release film-coated tablet. It is administered as a single oral dose with 150 mL of water under fasting conditions for the evaluation of pharmacokinetics in healthy adult male volunteers.
Pelubi CR + Zytram CRDrug
Also called Pelubiprofen 45 mg controlled-release tablet, Tramadol HCl 75 mg controlled-release tablet
The reference treatment consists of two separate controlled-release film-coated tablets: Pelubi CR (Pelubiprofen 45 mg) and Zytram CR (Tramadol HCl 75 mg). These are co-administered as a single oral dose with 150 mL of water under fasting conditions to compare the pharmacokinetic profile against the fixed-dose combination DW-1021.

Study groups in NCT07032558
Study group	Role	What they receive
Sequence A: Test → Reference	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. Receives: Drug: DW-1021; Drug: Pelubi CR + Zytram CR
Sequence B: Reference → Test	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. Receives: Drug: DW-1021; Drug: Pelubi CR + Zytram CR

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum plasma concentration (Cmax)
Cmax represents the peak plasma concentration of the drug after administration. It is used to compare the rate of absorption between the test and reference products.
Measured: 0 to 48 hours post-dose in each period
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt)
AUCt is a pharmacokinetic parameter representing the total drug exposure from administration to the last quantifiable time point. It is used to compare the extent of absorption between DW-1021 and the reference drugs.
Measured: 0 to 48 hours post-dose in each period

Secondary outcomes (3)

Area under the curve extrapolated to infinity (AUC∞)
AUC∞ represents the total drug exposure over time, extrapolated beyond the last measured concentration. It helps assess complete systemic exposure.
Measured: 0 to 48 hours post-dose in each period
Terminal elimination half-life (t1/2)
The time it takes for the plasma concentration of the drug to decrease by 50%. It is used to understand the drug elimination kinetics.
Measured: 0 to 48 hours post-dose in each period
Time to reach maximum plasma concentration (Tmax)
Tmax is defined as the time point at which the maximum plasma drug concentration is observed following drug administration. It is used to compare the absorption rate between DW-1021 and the reference products.
Measured: 0 to 48 hours post-dose in each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 202525 Oct 2025

First posted24 Jun 2025
Study start20 Sep 2025 (estimated)
Primary completion25 Sep 2025 (estimated)
Study completion25 Oct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This is a randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence (2x2) crossover study conducted under fasting conditions. Fourteen healthy male volunteers will be randomly assigned to one of two sequences: Test-Reference (Group A) or Reference-Test (Group B), with a 14-day washout period between dosing periods. The test drug (DW-1021, Pelubiprofen 45 mg - Tramadol 45.9 mg salt) or the reference drugs (Pelubi CR 45 mg and Zytram CR 75 mg) will be administered orally with 150 mL of water after at least 10 hours of fasting. Blood samples will be collected up to 48 hours post-dose in each period for pharmacokinetic evaluation.
Masking: None (open label)
Enrolment: 14 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07032558
Sponsor's protocol ID: DW-1021
Other IDs: Protocol No. DW-1021
Acronym: DW-1021
Status last verified: Aug 2025
First submitted: 15 Jun 2025
Last updated: 28 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared due to privacy concerns and the limited scope of the Phase I pharmacokinetic study in healthy volunteers. The study does not include plans or infrastructure for external data sharing.

Publications

Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
PubMed 25403311
Shin JS, Baek SR, Sohn SI, Cho YW, Lee KT. Anti-inflammatory effect of pelubiprofen, 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid, mediated by dual suppression of COX activity and LPS-induced inflammatory gene expression via NF-kappaB inactivation. J Cell Biochem. 2011 Dec;112(12):3594-603. doi: 10.1002/jcb.23290.
PubMed 21809372
Tham BT, Ngan TT, Van Anh T, Chool KD, Ram LA, Wook PS, Bok LS, Ho OD, Van Khai N, Phuong NTT. Pharmacokinetic Evaluation of a Fixed-Dose Combination of Pelubiprofen and Tramadol: A Randomized Crossover Relative Bioavailability Trial and a Fixed-Sequence Food-Effect Study in Healthy Volunteers. Clin Pharmacol Drug Dev. 2026 Mar;15(3):e70050. doi: 10.1002/cpdd.70050.
PubMed 41821212

Interested in taking part?

Nguyen Thi Thu Phuong, MD, PhD

+84936685007

nttphuong@hpmu.edu.vn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 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
ClinicalTrials.gov ID: NCT07032558
Acronym / sponsor ID: DW-1021 / DW-1021
Conditions: Healthy Volunteer
Keywords: Pelubiprofen, Tramadol, DW-1021, Pharmacokinetics, Fixed-Dose Combination, Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 14 participants (estimated)
Lead sponsor: Haiphong University of Medicine and PharmacyUniversity, hospital or other
Collaborators: Daewon Pharmaceutical Co., Ltd., Big Leap Research
Study start: 20 Sep 2025 (estimated)
Primary completion: 25 Sep 2025 (estimated)
Study completion: 25 Oct 2025 (estimated)
First posted: 24 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: This is a randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence (2x2) crossover study conducted under fasting conditions. Fourteen healthy male volunteers will be randomly assigned to one of two sequences: Test-Reference (Group A) or Reference-Test (Group B), with a 14-day washout period between dosing periods. The test drug (DW-1021, Pelubiprofen 45 mg - Tramadol 45.9 mg salt) or the reference drugs (Pelubi CR 45 mg and Zytram CR 75 mg) will be administered orally with 150 mL of water after at least 10 hours of fasting. Blood samples will be collected up to 48 hours post-dose in each period for pharmacokinetic evaluation.

Arm	Type	Receives
Sequence A: Test → Reference	Experimental	Drug: DW-1021, Drug: Pelubi CR + Zytram CRParticipants 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.
Sequence B: Reference → Test	Active comparator	Drug: DW-1021, Drug: Pelubi CR + Zytram CRParticipants 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.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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
Regular heart rate ranging from 60 to 90 beats per minute

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DW-1021Also: Pelubiprofen 45 mg - Tramadol 45.9 mg salt combination, Pelubiprofen-Tramadol fixed-dose combinationDW-1021 is a fixed-dose combination tablet containing Pelubiprofen 45 mg and Tramadol 45.9 mg (as a salt), formulated as a controlled-release film-coated tablet. It is administered as a single oral dose with 150 mL of water under fasting conditions for the evaluation of pharmacokinetics in healthy adult male volunteers.	Drug	Sequence A: Test → Reference, Sequence B: Reference → Test
Pelubi CR + Zytram CRAlso: Pelubiprofen 45 mg controlled-release tablet, Tramadol HCl 75 mg controlled-release tabletThe reference treatment consists of two separate controlled-release film-coated tablets: Pelubi CR (Pelubiprofen 45 mg) and Zytram CR (Tramadol HCl 75 mg). These are co-administered as a single oral dose with 150 mL of water under fasting conditions to compare the pharmacokinetic profile against the fixed-dose combination DW-1021.	Drug	Sequence A: Test → Reference, Sequence B: Reference → Test

Primary outcome

Maximum plasma concentration (Cmax)
Time frame: 0 to 48 hours post-dose in each period
Cmax represents the peak plasma concentration of the drug after administration. It is used to compare the rate of absorption between the test and reference products.
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt)
Time frame: 0 to 48 hours post-dose in each period
AUCt is a pharmacokinetic parameter representing the total drug exposure from administration to the last quantifiable time point. It is used to compare the extent of absorption between DW-1021 and the reference drugs.

3 secondary outcomes

Area under the curve extrapolated to infinity (AUC∞)
Time frame: 0 to 48 hours post-dose in each period
Terminal elimination half-life (t1/2)
Time frame: 0 to 48 hours post-dose in each period
Time to reach maximum plasma concentration (Tmax)
Time frame: 0 to 48 hours post-dose in each period

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
Background: PubMed 25403311Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.
Background: PubMed 21809372Shin JS, Baek SR, Sohn SI, Cho YW, Lee KT. Anti-inflammatory effect of pelubiprofen, 2-[4-(oxocyclohexylidenemethyl)-phenyl]propionic acid, mediated by dual suppression of COX activity and LPS-induced inflammatory gene expression via NF-kappaB inactivation. J Cell Biochem. 2011 Dec;112(12):3594-603. doi: 10.1002/jcb.23290.
Derived from this study: PubMed 41821212Tham BT, Ngan TT, Van Anh T, Chool KD, Ram LA, Wook PS, Bok LS, Ho OD, Van Khai N, Phuong NTT. Pharmacokinetic Evaluation of a Fixed-Dose Combination of Pelubiprofen and Tramadol: A Randomized Crossover Relative Bioavailability Trial and a Fixed-Sequence Food-Effect Study in Healthy Volunteers. Clin Pharmacol Drug Dev. 2026 Mar;15(3):e70050. doi: 10.1002/cpdd.70050.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and the limited scope of the Phase I pharmacokinetic study in healthy volunteers. The study does not include plans or infrastructure for external data sharing.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Nguyen Thi Thu Phuong, MD, PhD contact

+84936685007

nttphuong@hpmu.edu.vn

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DW-1021 and Pelubi CR + Zytram CR in people with Healthy Volunteer, run by Haiphong University of Medicine and Pharmacy at 2 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nguyen Thi Thu Phuong, MD, PhD (+84936685007, nttphuong@hpmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum plasma concentration (Cmax) (time frame: 0 to 48 hours post-dose in each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07032558, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.