To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Reference Drug or Test Drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT05433844

JW21103

Details and patient eligibility

About

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Full description

1. It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation.

   To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement.

2. All subjects who received more than one dose of clinical trial drugs are evaluated.

Enrollment: 44 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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44 participants in 2 patient groups

Group 1

Other group

Description:

Test Drug for Period I Reference Drug for Period II

Treatment:

Drug: Reference Drug or Test Drug

Group 2

Other group

Description:

Reference Drug for Period I Test Drug for Period II

Treatment:

Drug: Reference Drug or Test Drug