Pharmacokinetics and safety of DA-6034

Evaluation of Safety, Tolerability, and Pharmacokinetic Characteristics of DA-6034 in Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000793

Enrollment

Registered

2013-07-17

Start date

2003-07-23

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : 1)Single dose-ascending study: DA-6034 10mg, 20mg, 50mg, 100mg, 200mg or placebo was orally administered. 2)Multiple dose-ascending study: DA-6034 20mg, 50mg, 100mg or placebo tablets was orall

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) Healthy male adult subjects aged 19 to 45 years who are considered to be suitable to participate in the study based on prior examination within 3 weeks before the study commencement (2) Subjects with body weight of >45kg, and a within ±15% of ideal body weight ideal body weight = (Height(cm)-100)*0.9 (3) Subjects who voluntarily decided to partipate and gave written consent. (4) Subjects who are reliable, cooperative, obligible to limitations during the study

Exclusion criteria

Exclusion criteria: (1) Subjects with a previous history or present abnormal symtoms of cardiology, respiratory, renal, hepatic, gastrointestinal, and neurologic diseases (especially myocardial infarction, stroke, hypotension (SBP/DBP 150/95mmHg), coronary arterial diseases) (2) Subjects with a previous history of clinically significant allergies (e.g. asthma) (3) Subjects with hematological disorders (4) Subjects with febrile disease or infectious diseases within 2 weeks before the study commencement (5) Subjects who made whole blood donation within 2 months before the study commencement or blood component donation within 1 month before the study commencement (6) Subjects who have participated in another clinical study within 30 days before the commencement of study (7) Subjects with clinically significant neuropsychiatric disorders (8) Subjects with a previous history of drug abuse (9)Subjects with a previous history of drug allergies or other hypersensitivity reactions (10) Subjects who are positive for HBs antigen, HCV antibody, or HiV antibody at prior examination (11) Subjects who have continuous alcohol ingestion (>28 units/week) or do not agree to stop drinking during the study (12) Smokers (except subjects who quit smoking before 3 months before the study commencement) (13) Subjects who regularly administer over the counter medicine except prescribed medicine or vitamin/minerals (14) Subjects who have used any drugs within 7 days before the study commencement (15) Subjects who are permanently accommodated in a public institution

Design outcomes

Primary

Measure	Time frame
safety, tolerability	—

Secondary

Measure	Time frame
Pharmacokinetics of DA-6034	—

Countries

Korea, Republic of

Contacts

Public ContactJae-Yong Chung

Seoul National University Bundang Hospital

Outcome results