To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3); Drug: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3); Drug: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3); Drug: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3); Drug: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3); Drug: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06378684

JW22105

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 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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48 participants in 6 patient groups

Group 1

Other group

Description:

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Treatment:

Drug: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)

Group 2

Other group

Description:

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Treatment:

Drug: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)

Group 3

Other group

Description:

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Treatment:

Drug: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)

Group 4

Other group

Description:

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Treatment:

Drug: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)

Group 5

Other group

Description:

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Treatment:

Drug: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)

Group 6

Other group

Description:

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Treatment:

Drug: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)