Drug-drug Interaction Study Between UIC201601 and UIC201602

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: UIC201602 and co-administration of UIC201601 and UIC201602; Drug: UIC201601 and co-administration of UIC201601 and UIC201602

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment B	Drug: 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
Experimental: Treatment A	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma pharmacokinetics(AUCss,τ) 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
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
Plasma pharmacokinetics(AUCss,τ) 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
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

Collaborators and Investigators

• Sponsor: Korea United Pharm. Inc.
• Investigators: Principal Investigator: Janghee Hong, M.D.,Ph.D., Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2016
• Primary Completion (Actual): August 17, 2016
• Study Completion (Actual): August 17, 2016

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: KUP-UI018-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No