Status:
COMPLETED
PAC-14028 in Healthy Male Volunteers
Lead Sponsor:
Amorepacific Corporation
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
1. Primary Objective: * To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers. 2. Secondary Objective: * To evaluate pharmacokinetics a...
Eligibility Criteria
Inclusion
- Healthy men aged 20 to 45 years at the time of screening
- Whose weight is 50kg or more, but less than 90 kg, and whose body mass index(BMI) is 19.0 kg/m\^2 or more but less than 27 kg/m\^2
- BMI (kg/m\^2) = weight(kg) /{height(m)}\^2
- Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception.
Exclusion
- Who has clinically significant medical history or diseases involving liver, kidney, neurological system, respiratory system, endocrine system, urinary system, cardiovascular system, psychical disorders or blood tumor
- Who has gastrointestinal diseases or operation history which may interfere study drug absorption (however, except simple appendectomy and hernioplasty )
- Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)
- Who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
- Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
- Smoker or who has stopped smoking within previous 1 month or shows positive result at cotinine test.
- Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
- Who consistently consumes alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol)
- Who has participated in other clinical study within 12 weeks before study drug administration (however, the last dosing day is considered as the end of clinical study.)
- Who has had bleeding or blood collection and donation over 400 mL within 12 weeks before study drug administration
- Whose vital sign measured at sitting position after resting at least 5 minutes is as following
- Low blood pressure (Systolic pressure: 90 mmHg or less, Diastolic pressure: 50 mmHg or less)
- High blood pressure (Systolic pressure: 140 mmHg or higher, Diastolic pressure: 90 mmHg or less)
- Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01264224
Start Date
December 1 2010
Last Update
January 22 2014
Active Locations (1)
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1
Seoul National University Hospital Clinical Trials Center
Seoul, South Korea, 110-744