Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT06378684
  4. Details
NCT06378684 Clinical Trial

To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

Healthy Clinical Trial

Official title:
A Randomized, Open-label, Multiple-dose, 6×3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of JW0104 and C2207 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06378684
Other study ID # JW22105
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 10, 2023
Est. completion date January 13, 2024

Study information
Verified date April 2024
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Description:

Pharmacokinetic Interactions: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date January 13, 2024
Est. primary completion date December 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility Inclusion Criteria: - Healthy volunteers Exclusion Criteria: - Subjects does not meet the Inclusion Criteria

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
• Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
• Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
• Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
• Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration
• Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)
Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Locations
Country Name City State
Korea, Republic of Clinical Trial Center, Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax,ss Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)
Primary AUCt,ss Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group. Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 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 NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
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 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 NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
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