Drug-drug Interaction Study Between UIC201601 and UIC201602

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190133
• Other study ID #: KUP-UI018-101
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2016
• Est. completion date: August 17, 2016

Study information

• Verified date: January 2022
• Source: Korea United Pharm. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 17, 2016
• Est. primary completion date: August 17, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• UIC201602 and co-administration of UIC201601 and UIC201602
UIC201602 4 Cap/day for 14 days Wash out 21 days UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days
• UIC201601 and co-administration of UIC201601 and UIC201602
UIC201601 4 Tab/day for 7 days Wash out 14 days UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea United Pharm. Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma pharmacokinetics(AUCss,t) of UIC201602	Area under the serum drug concentration-time curve within a dosing interval at steady state	0 hour to 24 hours after Day 14 and Day 49 administration
Primary	Plasma pharmacokinetics(Css,max) of UIC201602	Maximum concentration of drug in serum at steady state	0 hour to 24 hours after Day 14 and Day 49 administration
Primary	Plasma pharmacokinetics(AUCss,t) of UIC201601	Area under the serum drug concentration-time curve within a dosing interval at steady state	0 hour to 24 hours after Day 7 and Day 35
Primary	Plasma pharmacokinetics(Css,max) of UIC201601	Maximum concentration of drug in serum at steady state	0 hour to 24 hours after Day 7 and Day 35