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NCT Number: NCT06492655

To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers

This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers

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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–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Participants were randomly assigned in a 1:1 ratio. TheParticipants are prescribed oral administration of the appropriate IP(2 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 54 years
BMI measurement result is 18.0 kg/m2 to 30 kg/m2
Written informed consent
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

CKD-383(Fed)

Drug

After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.

Other names: Lobeglitazone, Empagliflozin, Metformin

CKD-383(Fasted)

Drug

After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.

Other names: Lobeglitazone, Empagliflozin, Metformin

Primary outcomes

AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)

Time frame: 0 hour ~ 48 hour after drug administration

Pharmacokinetic characterization
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)

Time frame: 0 hour ~ 48 hour after drug administration

Pharmacokinetic characterization

Study contacts

Contact information is provided by the study sponsor or research team.

Jisoo Kim, PL

CONTACT

[email protected]

02-6373-0785

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 9, 2024
Registry last updated: Jul 10, 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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