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

An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04479865

Enrollment

Registered

2020-07-21

Start date

2020-07-28

Completion date

2021-04-30

Last updated

2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGAricept 5mg Tablet

1 tablet once daily

DRUGAricept 10mg Tablet

1 tablet once daily

DRUGDA-5207 150mg

1 patch once weekly

DRUGDA-5207 170mg

1 patch once weekly

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026