Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DA-2811; Drug: DA-2811-R

• Registration Number: NCT04938752
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-24
• Study Start: 2021-07-08
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy male and/or female subjects
• BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
• Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress

Exclusion Criteria

• Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence I	DA-2811	-
Sequence II	DA-2811	-
Sequence II	DA-2811-R	-
Sequence I	DA-2811-R	-

Primary Outcome Measures

Name	Time	Method
AUClast	pre-dose~48 hours post-dose	Area under the plasma concentration-time curve from time zero to time the last quantifiable time
Cmax	pre-dose~48 hours post-dose	Maximum plasma concentration

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Seongnam-si, Korea, Republic of