Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin

Daewon Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: DW4421-1; Drug: DW4421-2; Drug: DW4421

Study type: Interventional

Funder types: Industry

Identifiers

NCT07382661

DW4421-103

Details and patient eligibility

About

Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin

Enrollment: 36 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Inclusion Criteria:
• Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
• Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

Exclusion criteria

• Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Sequence 1

Experimental group

Description:

A-B-C (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Treatment:

Drug: DW4421

Drug: DW4421-2

Drug: DW4421-1

Sequence 2

Experimental group

Description:

A-C-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Treatment:

Drug: DW4421

Drug: DW4421-2

Drug: DW4421-1

Sequence 3

Experimental group

Description:

B-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Treatment:

Drug: DW4421

Drug: DW4421-2

Drug: DW4421-1

Sequence 4

Experimental group

Description:

B-C-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Treatment:

Drug: DW4421

Drug: DW4421-2

Drug: DW4421-1

Sequence 5

Experimental group

Description:

C-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Treatment:

Drug: DW4421

Drug: DW4421-2

Drug: DW4421-1

Sequence 6

Experimental group

Description:

C-B-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Treatment:

Drug: DW4421

Drug: DW4421-2

Drug: DW4421-1