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OpenTrials
Completed

NCT Number: NCT05127746

Phase 1 Clinical Trial of DA-5207 in Healthy Adults

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics 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

Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Aricept 5mg Tablet

Drug

1 tablet once daily

Aricept 10mg Tablet

Drug

1 tablet once daily

DA-5207 A

Drug

1 patch once weekly

DA-5207 B

Drug

1 patch once weekly

Primary outcomes

  1. AUC

    Time frame: 29-36 days

    area under the concentration-time curve

  2. Css,max

    Time frame: 0-36 days

    maximum serum concentration at steady state

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
Apr 14, 2023

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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