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Completed

NCT Number: NCT06483243

Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.

This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, South Korea

About this study

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 tablets in single dose: actual medication)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged 19 to 65 years
  • Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
  • within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
  • Other inclusion criteria, as defined in the protocol

Exclusion criteria

  • who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period 1 administration)
  • Other exclusive criteria, as defined in the protocol

Treatment and study plan

Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG

Drug

At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature.

Other names: Test: CKD-383, Reference1: CKD-501, Reference2: D745, Reference3: D150

Primary outcomes

  1. AUCt of Lobeglitazone, Empagliflozin, Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Pharmacokinetic characterization

  2. Cmax of Lobeglitazone, Empagliflozin, Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Pharmacokinetic characterization

Secondary outcomes

  1. AUC∞ of Lobeglitazone, Empagliflozin, Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Pharmacokinetic characterization

  2. Tmax of Lobeglitazone, Empagliflozin, Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Pharmacokinetic characterization

  3. T1/2 of Lobeglitazone, Empagliflozin, Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Pharmacokinetic characterization

  4. CL/F of Lobeglitazone, Empagliflozin, Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Pharmacokinetic characterization

  5. Vd/F of Lobeglitazone, Empagliflozin, Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Pharmacokinetic characterization

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D745, and D150 for Healthy Subjects in Fed State

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

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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