Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults

Dong-A ST

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Aricept 10mg Tablet; Drug: Aricept 5mg Tablet; Drug: DA-5207 150mg; Drug: DA-5207 170mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04479865

DA5207_AD_Ib

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults

Enrollment: 49 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health Voulunterrs (Age : 19~55 years)
• Body Weight : Male≥55kg, Female≥50kg
• 18.5 ≤BMI≤ 25.0

Exclusion criteria

• Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
• Allergy or Drug hypersensitivity
• Clinically significant Medical History
• AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73m²
• Heavy alcohol intake (more than 210g/week)
• Heavy smoker (more than 10 cigarettes/day)
• Heavy caffeine intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 4 patient groups

Sequence 1

Experimental group

Description:

Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg

Treatment:

Drug: DA-5207 150mg

Drug: Aricept 10mg Tablet

Drug: Aricept 5mg Tablet

Sequence 2

Experimental group

Description:

Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg

Treatment:

Drug: DA-5207 150mg

Drug: Aricept 10mg Tablet

Drug: Aricept 5mg Tablet

Sequence 3

Experimental group

Description:

Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg

Treatment:

Drug: DA-5207 170mg

Drug: Aricept 10mg Tablet

Drug: Aricept 5mg Tablet

Sequence 4

Experimental group

Description:

Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg

Treatment:

Drug: DA-5207 170mg

Drug: Aricept 10mg Tablet

Drug: Aricept 5mg Tablet