Phase 1 Clinical Trial of DA-5207 in Healthy Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Aricept 5mg Tablet; Drug: Aricept 10mg Tablet; Drug: DA-5207 A; Drug: DA-5207 B

• Registration Number: NCT05127746
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-19
• Study Start: 2021-11-25
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Health Volunteers (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 caffeine intake
• Heavy alcohol intake (more than 210g/week)
• Heavy smoker (more than 10 cigarettes/day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 4	Aricept 5mg Tablet	Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 B
Sequence 1	Aricept 5mg Tablet	Period 1, Aricept 5mg → DA-5207 A; Period 2, Aricept 5mg → Aricept 10mg
Sequence 1	Aricept 10mg Tablet	Period 1, Aricept 5mg → DA-5207 A; Period 2, Aricept 5mg → Aricept 10mg
Sequence 1	DA-5207 A	Period 1, Aricept 5mg → DA-5207 A; Period 2, Aricept 5mg → Aricept 10mg
Sequence 2	Aricept 5mg Tablet	Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 A
Sequence 2	Aricept 10mg Tablet	Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 A
Sequence 2	DA-5207 A	Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 A
Sequence 3	Aricept 5mg Tablet	Period 1, Aricept 5mg → DA-5207 B; Period 2, Aricept 5mg → Aricept 10mg
Sequence 3	Aricept 10mg Tablet	Period 1, Aricept 5mg → DA-5207 B; Period 2, Aricept 5mg → Aricept 10mg
Sequence 3	DA-5207 B	Period 1, Aricept 5mg → DA-5207 B; Period 2, Aricept 5mg → Aricept 10mg
Sequence 4	Aricept 10mg Tablet	Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 B
Sequence 4	DA-5207 B	Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 B

Primary Outcome Measures

Name	Time	Method
AUC	29-36 days	area under the concentration-time curve
Css,max	0-36 days	maximum serum concentration at steady state

Trial Locations

Locations (1)

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Jeonbuk, Korea, Republic of