A Clinical Study to Evaluate the Safety and the Pharmacokinetics of UI068 in Healthy Adult Volunteers Under Fed Conditions

November 15, 2023 updated by: Korea United Pharm. Inc.
This study was open-label, randomized, fed, single-dose, 2-groups, 2 periods, crossover designe to compare the safety and pharmacokinetics of UI068 and co-administration of UIC202205 and UIC202206.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gwanak-gu
      • Seoul, Gwanak-gu, Korea, Republic of, 08779
        • H Plus Yangji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy subjects over the ages of 19 at screening
  • Subjects whose body weight over 60 kg and having a body mass index (BMI) of over than 18.0 and less than 30.0 kg/m2 at screening (☞ BMI(kg/m2) = Weight(kg)/{Height(m)}2)
  • There are no clinically significant congenital diseases/chronic diseases/ pathological symptoms or finding at the screening
  • he principal investigator determines to be suitable test subjects as a result of diagnostic tests and electrocardiogram tests etc.
  • From the date of first to the last administration of the investigational drug Until 7 weeks , tester or spouse or partner must use a method of contraception recognized in clinical trials.
  • The tester who is signed after being explained and understanding about purpose and content of this clinical trial, characteristics of the investigational drug.

Exclusion Criteria:

  • Clinically significant diseases related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious disease, kidney and genitourinary system, mental/nervous system, musculoskeletal system, immune system, ENT system, skin system, and ophthalmic system. Those who have or have a history of
  • Those with a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect drug absorption or gastrointestinal disease
  • Those who took drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month of the first dose, or took drugs that may interfere with this clinical trial within 10 days of the first dose.
  • A person who participated in another clinical trial or bioequivalence test and administered an investigational drug within 6 months of the first administration date
  • Those who donated whole blood or component blood within 2 weeks or received a blood transfusion within 4 weeks of the first administration date

  • Those who meet the following conditions within 1 month of the first medication date

    • Alcohol consumption exceeding 21 drinks/week on average for men

    • For women, alcohol consumption exceeds an average of 14 drinks/week

      (1 glass = 50 mL of soju or 30 mL of liquor or 250 mL of beer)

    • Smoking more than 20 cigarettes per day on average

  • Those who fall under the following

    • Patients with hypersensitivity to clinical investigational drugs or ingredients contained in clinical investigational drugs
    • Persons with a history of hypersensitivity to biguanide drugs

  • Patients with the following diseases

    • Patients with moderate (stage3b) and severe renal impairment (eGFR<45mL/min/1.73m2), Acute conditions that can affect kidney function, such as diabetes, serious infections, cardiovascular collapse (shock), acute myocardial infarction, and sepsis
    • Patients with acute and unstable heart failure
    • Patients undergoing tests requiring intravenous administration of radioiodine contrast material (e.g., intravenous urography, intravenous cholangiography, angiography, computed tomography using contrast agent, etc.)
    • Patients with acute or chronic metabolic acidosis, including type 1 diabetes, lactic acidosis, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis
    • Diabetic precoma
    • Patients with severe infections or severe traumatic systemic disorders
    • Patients with malnutrition, starvation, weakness, pituitary dysfunction or adrenal dysfunction
    • Patients with acute or chronic diseases that can cause tissue hypoxia such as liver dysfunction, respiratory failure, acute myocardial infarction, and shock, excessive alcohol intake, and gastrointestinal disorders such as dehydration, diarrhea, and vomiting
  • Persons judged by the principal investigator to be unsuitable for participation in this clinical trial for reasons other than the above selection/exclusion criteria
  • For female volunteers, those who are pregnant, suspected of being pregnant, or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: UI068
Drug: administration of UI068
Test
Experimental: UIC202205, UIC202206
Drug: administration of UIC202205, UIC202206
Reference

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: 0 to 72hr
Evaluation PK for Linagliptin and Metformin after single dose
0 to 72hr
Cmax
Time Frame: 0 to 72hr
Evaluation PK for Linagliptin and Metformin after single dose
0 to 72hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea United Pharm. Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KUP-UI068-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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