DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: DW-0920 (Drug); DW-0919 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Daewon Pharmaceutical Co., Ltd.

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

AUC of DW-0919(Acetaminophen, Tramadol)

Cmax of DW-0919(Acetaminophen, Tramadol)

AUC of DW-0920(Acetaminophen, Tramadol)

Cmax of DW-0920(Acetaminophen, Tramadol)

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Chungnam National University Hospital, DaeJeon, Korea, Republic of
Additional Information

Starting date: May 2012
Last updated: January 21, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017