Status:
COMPLETED
Drug-drug Interaction Study Between UIC201601 and UIC201602
Lead Sponsor:
Korea United Pharm. Inc.
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief Summary
An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.
Eligibility Criteria
Inclusion
- Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
- Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
- Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
- Subjects able to read and understand a written informed consent, and willing to participate in the study.
Exclusion
- Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc);
- Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination;
- Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor;
- Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish;
- Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption;
- etc.
Key Trial Info
Start Date :
May 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05190133
Start Date
May 28 2016
End Date
August 17 2016
Last Update
January 13 2022
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