FindTrial
Sign In

Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition

A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01606059
Acronym
DW0919-1003
Enrollment
30
Registered
2012-05-25
Start date
2012-05-31
Completion date
2012-06-30
Last updated
2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.

Interventions

DRUGDW-0920

Dosage form: Extended release tablet Dosage: 2 tablets

DRUGDW-0919

Dosage form: Extended release tablet Dosage: 1 tablet

Sponsors

Chungnam National University Hospital
CollaboratorOTHER
Daewon Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult males aged 20 to 55 years at screening. * No significant congenital/chronic disease. * No symptoms in physical examination. * Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. * Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion criteria

* History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids. * History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. * History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

Design outcomes

Primary

MeasureTime frame
AUC of DW-0919(Acetaminophen, Tramadol)0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0919(Acetaminophen, Tramadol)0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
AUC of DW-0920(Acetaminophen, Tramadol)0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36
Cmax of DW-0920(Acetaminophen, Tramadol)0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026