Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition (DW0919-1003)

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DW-0920; Drug: DW-0919

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01606059

DW0919-1003

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

DW-0919

Active Comparator group

Treatment:

Drug: DW-0919

DW-0920

Experimental group

Treatment:

Drug: DW-0920