A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B

Overview

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.

Full Title of Study: “An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2022

Detailed Description

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male subjects.

Interventions

  • Drug: AD-221
    • AD-221 Oral Tablet
  • Drug: AD-221A and AD-221B
    • AD-221A Oral Tablet + AD-221B Oral Tablet

Arms, Groups and Cohorts

  • Experimental: Sequence A
    • Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)
  • Experimental: Sequence B
    • Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)

Clinical Trial Outcome Measures

Primary Measures

  • Peak Plasma Concentration (Cmax)
    • Time Frame: pre-dose to 72 hours
    • Cmax of AD-221
  • Area Under the Curve in time plot (AUCt)
    • Time Frame: pre-dose to 72 hours
    • AUCt of AD-221

Participating in This Clinical Trial

Inclusion Criteria

  • Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit – The Age equal to or greater than 19 in healthy volunteers at the time of screening visit Exclusion Criteria:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system – Subjects who judged ineligible by the investigator

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Addpharma Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Si-Beum Lee, Ph.D, +82-31-5696, sblee@addpharma.co.kr

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