Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04272502

A86_02BE1902P

Details and patient eligibility

About

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers

Enrollment: 15 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 19 ≤ age ≤ 45
2. Health Volunteers
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion criteria

1. Subject who cannot participate in a clinical trial based on the PI's judgment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Sequence A

Experimental group

Description:

CKD-828, D326, D337, CKD-F1, CKD-F2

Treatment:

Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Sequence B

Experimental group

Description:

CKD-828, D326, D337, CKD-F1, CKD-F2

Treatment:

Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Sequence C

Experimental group

Description:

CKD-828, D326, D337, CKD-F1, CKD-F2

Treatment:

Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337