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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05190133

Enrollment

Registered

2022-01-13

Start date

2016-05-28

Completion date

2016-08-17

Last updated

2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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 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(Css,max) of UIC201601	0 hour to 24 hours after Day 7 and Day 35	Maximum concentration of drug in serum at steady state

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026