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OpenTrials
Completed

NCT Number: NCT04013477

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

Completed

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials Center, Severance Hospital

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-5207

Drug

DA-5207 Transdermal Delivery System

Donepezil Hydrochloride

Drug

donepezil HCl 10mg QD

Other names: Aricept

Primary outcomes

  1. AUC

    Time frame: patch : 21days, oral : 11days

    area under the concentration-time curve

  2. Cmax

    Time frame: patch : 21days, oral : 11days

    maximum serum concentration

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 9, 2019
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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