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.

Phase 1

• Conditions: Healthy
• Interventions: Drug: DA-5216; Drug: DA-5216-R

• Registration Number: NCT05506007
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-18
• Study Start: 2022-08-29
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-23
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
[Part A] DA-5216	DA-5216	-
[Part A] DA-5216-R	DA-5216-R	-
[Part B] DA-5216(Fed)	DA-5216	-
[Part B] DA-5216(Fasting)	DA-5216	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Soeul, Korea, Republic of