Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-01 @ 5:04 AM
Study NCT ID:
NCT07032558
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of DW-1021 and Separate Doses of Pelubi CR and Zytram CR Under Fasting Conditions
Sponsor:
Haiphong University of Medicine and Pharmacy
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DW-1021
Brief Summary:
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Protocol No. DW-1021 | OTHER | Daewon Pharmaceutical Co., Ltd. | View |