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CompletedNCT05190133Updated Jan 13, 2022

Drug-drug Interaction Study Between UIC201601 and UIC201602

A Phase 1 interventional study of UIC201602 and co-administration of UIC201601 and UIC201602 and UIC201601 and co-administration of UIC201601 and UIC201602 in Healthy, sponsored by Korea United Pharm. Inc.. Completed. Open to male participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Korea United Pharm. Inc. · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 5 years 6 months after the study started (first participant enrolled May 2016, registered Dec 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Korea United Pharm. Inc. is the lead sponsor of 21 studies on the registry; 5 are open to participants now.

Browse Korea United Pharm. Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Treatment A

    Drug: UIC201602 and co-administration of UIC201601 and UIC201602

  • Experimental
    Treatment B

    Drug: UIC201601 and co-administration of UIC201601 and UIC201602

Interventions

  • DrugUIC201602 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

  • DrugUIC201601 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

06

What researchers measure

Primary outcomes

  1. Plasma pharmacokinetics(AUCss,τ) of UIC201602

    Area under the serum drug concentration-time curve within a dosing interval at steady state

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

  2. Plasma pharmacokinetics(Css,max) of UIC201602

    Maximum concentration of drug in serum at steady state

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

  3. Plasma pharmacokinetics(AUCss,τ) of UIC201601

    Area under the serum drug concentration-time curve within a dosing interval at steady state

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

  4. Plasma pharmacokinetics(Css,max) of UIC201601

    Maximum concentration of drug in serum at steady state

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2016 to primary completion in Aug 2016, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2021
First posted
Jan 13, 2022
StartActual
May 28, 2016
Primary completionActual
Aug 17, 2016
CompletionActual
Aug 17, 2016
Last update
Jan 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05190133
Lead sponsor
Korea United Pharm. Inc.
Responsible party
Sponsor
First posted
Jan 13, 2022
Start date
May 28, 2016
Primary completion
Aug 17, 2016
Completion
Aug 17, 2016
Last update
Jan 13, 2022

Study contacts

Janghee Hong, M.D.,Ph.D.
principal investigator · Chungnam National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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