Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects

• Sponsor: Dong-A ST Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03200496
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 1
• Patients Per Site Per Month: 29.5

Study Details

Study Description

Brief Summary

This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DA-5206(Fasting); Drug: DA-5206(Fed); Drug: TALION®	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparisons of Pharmacokinetics and Safety/Tolerability Profiles Between DA-5206 and Talion® Under Fasting and Fed States in Healthy Male Subjects
• Actual Study Start Date: May 29, 2017
• Actual Primary Completion Date: Jun 29, 2017
• Actual Study Completion Date: Jun 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TALION®	Drug: TALION®; Reference drug : Talion®
Experimental: DA-5206(Fasting)	Drug: DA-5206(Fasting); Test drug l : DA-5206(Fasting)
Experimental: DA-5206(Fed)	Drug: DA-5206(Fed); Test drug ll : DA-5206(Fed)

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration versus time curve (AUC) [0~24hr]

   PK Parameter

2. Peak Plasma Concentration (Cmax) [0~24hr]

   PK Parameter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male volunteer 19 years to 45 years

• Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg

• The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate

Exclusion Criteria:

• Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease

• Subject with acute disease within 28 days before the first dose of Investigational product

• Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug

• Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Dong-A ST Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong-A ST Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03200496
• Other Study ID Numbers: DA5206_BE_Ⅰ
• First Posted: Jun 27, 2017
• Last Update Posted: Jul 11, 2017
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 11, 2017