A Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" Under Fed Conditions in Healthy Adult Volunteers

NCT ID: NCT05959499

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-13
• Study Completion Date: 2023-09-12

Brief Summary

The purpose of this clinical trial is evaluate the pharmacokinetics and safety between single administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fed conditions in healthy adult volunteers

Conditions

Gastric or Duodenal Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BR6002A+BR6002B

Group Type: ACTIVE_COMPARATOR

BR6002A

Intervention Type: DRUG

One tablet administered alone

BR6002B

Intervention Type: DRUG

One tablet administered alone

BR6002

Group Type: EXPERIMENTAL

BR6002

Intervention Type: DRUG

One capsule administered alone

Interventions

BR6002A

One tablet administered alone

Intervention Type: DRUG

BR6002B

One tablet administered alone

Intervention Type: DRUG

BR6002

One capsule administered alone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Those who weigh 55 kg or more for men and 50 kg or more for women and have body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 at screening.
• Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (In the case of a female subject, hormone drugs is excluded) accepted in clinical trial from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum.

• Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
• Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc.

Exclusion Criteria

• Those who have clinically significant diseases or past history of the gastrointestinal system, cardiovascular system, endocrine system, respiratory system, hemato-oncologic disease, infectious disease, kidney & genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, ENT system, skin system, ophthalmic system.
• Those who have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
• Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 1month prior to the first day of administration or have taken ETC, OTC, herbal medicine and health functional foods concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs)
• Those who have participated in other clinical trials or bioequivalence tests and administered their investigational products within 6 months prior to the first administration date.
• Those who are unable to consume high-fat meals provided during this clinical trial.
• In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Center, H PLUS Yangji Hospital

Seoul, Gwanakgu, South Korea

Countries

South Korea

Other Identifiers

BR-ARC-CT-103

Identifier Type: -

Identifier Source: org_study_id