NCT06141590

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

November 15, 2023

Last Update Submit

November 15, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Evaluation PK for Linagliptin and Metformin after single dose

    0 to 72hr

  • Cmax

    Evaluation PK for Linagliptin and Metformin after single dose

    0 to 72hr

Study Arms (2)

UI068

EXPERIMENTAL
Drug: administration of UI068

UIC202205, UIC202206

EXPERIMENTAL
Drug: administration of UIC202205, UIC202206

Interventions

administration of UI068DRUG

Test

UI068
administration of UIC202205, UIC202206DRUG

Reference

UIC202205, UIC202206

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

March 11, 2023

Primary Completion

August 29, 2023

Study Completion

August 29, 2023

Last Updated

November 21, 2023

Record last verified: 2023-02

Locations

KR(1)