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Completed

NCT Number: NCT05190133

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.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Plasma pharmacokinetics(AUCss,τ) of UIC201602

    Time frame: 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

  2. Plasma pharmacokinetics(Css,max) of UIC201602

    Time frame: 0 hour to 24 hours after Day 14 and Day 49 administration

    Maximum concentration of drug in serum at steady state

  3. Plasma pharmacokinetics(AUCss,τ) of UIC201601

    Time frame: 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

  4. Plasma pharmacokinetics(Css,max) of UIC201601

    Time frame: 0 hour to 24 hours after Day 7 and Day 35

    Maximum concentration of drug in serum at steady state

Sponsors and collaborators

Lead sponsor

Korea United Pharm. Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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