Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults

A Single-blinded, Placebo- and Active-controlled, Parallel, Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DA-5207 Transdermal Delivery System in Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04013477

Enrollment

Registered

2019-07-09

Start date

2019-06-18

Completion date

2020-04-06

Last updated

2021-04-14

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

Conditions

Healthy

Brief summary

A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults

Interventions

DRUGDA-5207

DA-5207 Transdermal Delivery System

DRUGDonepezil Hydrochloride

donepezil HCl 10mg QD

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
AUC	patch : 21days, oral : 11days	area under the concentration-time curve
Cmax	patch : 21days, oral : 11days	maximum serum concentration

Countries

South Korea

Outcome results

None listed

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