A Clinical Trial to Compare the Safety, Tolerability, and PK Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216.

A Randomized, Open-label, Single Dose, Cross-over Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetic Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216 in Healthy Adult Subjects.

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05506007

Enrollment

Registered

2022-08-18

Start date

2022-08-29

Completion date

2022-10-31

Last updated

2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This is a randomized, open-label, single dose, 2-part, cross-over clinical trial to compare the safety, tolerability, and pharmacokinetic properties of DA-5216 and DA-5216-R and to evaluate the food effect on DA-5216 in healthy adult subjects

Interventions

DRUGDA-5216

During the cross-over \[Part A\], patients will be randomly assigned to receive one of the following treatment sequences: * Sequence I. Single dose of DA-5216-R(Fasting) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8. * Sequence II. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216-R(Fasting) on Day 8.

DRUGDA-5216-R

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female volunteer 19 years to 50 years * Body weight in the range of 50.0kg and body mass index in the range of 18 to 27kg/m2 * Subject who are negative in pregnancy test or pregnant or Lactating women * The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate * The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion criteria

* Subject with serious active hepatobiliary, respiratory, digestive, hematologic, endocrine(diabetes mellitus, aldosteronism), immunologic, cardiovascular(hypertension, angina, heart failure, myocardial infarction, etc.), neurologic, urologic, otorhinolaryngologic, musculoskeletal, psychological disease or history of such disease * Subject with gastrointestinal disease (Crohn's disease, peptic ulcer, acute or chronic pancreatitis, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery). * Subject who have galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption * Subject who have had one or more of the following findings * AST, ALT \> 1.5 times the upper limit * CPK \> 2.5 times the upper limit * eGFR \<60mL/min/1.73m2

Design outcomes

Primary

Measure	Time frame
Peak Plasma Concentration (Cmax) PK parameter	0~48hours
Area under the plasma concentration versus time curve (AUClast) PK parameter	0~48hours

Countries

South Korea

Contacts

Primary ContactSeung Hwan Lee, PhD

leejh413@snu.ac.kr02-2072-2343

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026