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

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment D; Drug: Treatment C; Drug: Treatment E; Drug: Treatment A; Drug: Treatment B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05463497

JW21101

Details and patient eligibility

About

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

Full description

1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Enrollment: 40 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

• Subjects does not meet the Inclusion Criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Group 1(N=10)

Other group

Description:

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

Treatment:

Drug: Treatment B

Drug: Treatment A

Drug: Treatment C

Group 2(N=10)

Other group

Description:

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

Treatment:

Drug: Treatment B

Drug: Treatment A

Drug: Treatment C

Group 3(N=10)

Other group

Description:

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

Treatment:

Drug: Treatment D

Drug: Treatment A

Drug: Treatment E

Group 4(N=10)

Other group

Description:

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

Treatment:

Drug: Treatment D

Drug: Treatment A

Drug: Treatment E