Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06357910
Other study ID # HM-EMMA-102
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 17, 2024
Est. completion date June 29, 2024

Study information

Verified date April 2024
Source Hanmi Pharmaceutical Company Limited
Contact NaYoung Kim
Phone 02-410-9165
Email skyko7@hanmi.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fed condition in healthy volunteers.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date June 29, 2024
Est. primary completion date June 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 54 Years
Eligibility Inclusion Criteria: - Age 19~54 years in healthy volunteers - 18.5 kg/m^2 = BMI < 30 kg/m^2, weight(men) =55kg / weight(women) =45kg - 90 mmHg = sitSBP <140 mmHg, 50 mmHg = sitDBP <90 mmHg - Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug - Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial Exclusion Criteria: - Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system - Subjects who cannot consume the high-fat meal provided during this clinical trial - Subjects who judged ineligible by the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HCP2303
Take 1 tablet once per period
RLD2302
Take 1 tablet once per period
RLD2102
Take 1 tablet once per period

Locations

Country Name City State
Korea, Republic of Jeonbuk University Hospital Jeonju Jeollabuk-do

Sponsors (1)

Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUCt Pharmacokinetic evaluation 0~48 hours
Primary Cmax Pharmacokinetic evaluation 0~48 hours
Secondary AUCinf Pharmacokinetic evaluation 0~48 hours
Secondary Tmax Pharmacokinetic evaluation 0~48 hours
Secondary t1/2 Pharmacokinetic evaluation 0~48 hours
Secondary CL/F Pharmacokinetic evaluation 0~48 hours
Secondary Vd/F Pharmacokinetic evaluation 0~48 hours
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1