Drug-drug Interaction Study Between UIC201601 and UIC201602

NCT05190133 | Completed Phase 1

• 1 other identifier: KUP-UI018-101
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Treatment A

EXPERIMENTAL

Drug: UIC201602 and co-administration of UIC201601 and UIC201602

Treatment B

EXPERIMENTAL

Drug: UIC201601 and co-administration of UIC201601 and UIC201602

Interventions

UIC201602 and co-administration of UIC201601 and UIC201602 DRUG

* UIC201602 4 Cap/day for 14 days * Wash out 21 days * UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days

Treatment A

UIC201601 and co-administration of UIC201601 and UIC201602 DRUG

* UIC201601 4 Tab/day for 7 days * Wash out 14 days * UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days

Treatment B

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Officials

• Janghee Hong, M.D.,Ph.D.

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 13, 2022
• Study Start: May 28, 2016
• Primary Completion: August 17, 2016
• Study Completion: August 17, 2016
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share