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

• Status: Completed
• Trial end date: 2020-04-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Donepezil

Criteria

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