Drug-drug Interaction Study Between UIC201601 and UIC201602

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: UIC201601 and co-administration of UIC201601 and UIC201602; Drug: UIC201602 and co-administration of UIC201601 and UIC201602

• Registration Number: NCT05190133
• Lead Sponsor: Korea United Pharm. Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-28
• Primary Completion: 2016-08-17
• Study Completion: 2016-08-17
• Study First Submitted: 2021-12-22
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-13
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment B	UIC201601 and co-administration of UIC201601 and UIC201602	-
Treatment A	UIC201602 and co-administration of UIC201601 and UIC201602	-

Primary Outcome Measures

Name	Time	Method
Plasma pharmacokinetics(Css,max) of UIC201602	0 hour to 24 hours after Day 14 and Day 49 administration	Maximum concentration of drug in serum at steady state
Plasma pharmacokinetics(AUCss,τ) of UIC201601	0 hour to 24 hours after Day 7 and Day 35	Area under the serum drug concentration-time curve within a dosing interval at steady state
Plasma pharmacokinetics(AUCss,τ) of UIC201602	0 hour to 24 hours after Day 14 and Day 49 administration	Area under the serum drug concentration-time curve within a dosing interval at steady state
Plasma pharmacokinetics(Css,max) of UIC201601	0 hour to 24 hours after Day 7 and Day 35	Maximum concentration of drug in serum at steady state