To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

NCT05463497 | Completed Phase 1

• 1 other identifier: JW21101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax,ss

  Cmax,ss of each drug

  up to 12hour(or 24hour) after administration

• AUCτ,ss

  AUCτ,ss of each drug

  up to 12hour(or 24hour) after administration

Secondary Outcomes (5)

• Cmin,ss

  up to 12hour(or 24hour) after administration

• Tmax,ss

  up to 12hour(or 24hour) after administration

• CLss/F

  up to 12hour(or 24hour) after administration

• Vdss/F

  up to 12hour(or 24hour) after administration

• fluctuation

  up to 12hour(or 24hour) after administration

Study Arms (4)

Group 1(N=10)

OTHER

Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3 \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Group 2(N=10)

OTHER

Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3

Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Group 3(N=10)

OTHER

Treatment A for Period I Treatment E Treatment D \*Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3

Drug: Treatment A; Drug: Treatment D; Drug: Treatment E

Group 4(N=10)

OTHER

Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3 \*Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3

Drug: Treatment A; Drug: Treatment D; Drug: Treatment E

Interventions

Treatment A DRUG

JW0201: single administration, Tablet, Oral, BID for 5 days

Group 1(N=10); Group 2(N=10); Group 3(N=10); Group 4(N=10)

Treatment B DRUG

C2103: single administration, Tablet, Oral, BID for 5 days

Group 1(N=10); Group 2(N=10)

Treatment C DRUG

JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days

Group 1(N=10); Group 2(N=10)

Treatment D DRUG

C2104 : single administration, Tablet, Oral, QD for 5 days

Group 3(N=10); Group 4(N=10)

Treatment E DRUG

JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days

Group 3(N=10); Group 4(N=10)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Jeonbuk National University Hospita

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Officials

• Min-Gul Kim, PI

  Jeonbuk National University Hospita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, open-label, multiple-dose, 2x3 crossover clinical trial

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 19, 2022
• Study Start: January 17, 2022
• Primary Completion: March 16, 2022
• Study Completion: March 23, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

KR (1)