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

NCT05959486 | Completed Phase 1

• 1 other identifier: BR-ARC-CT-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric or Duodenal Ulcers

Outcome Measures

Primary Outcomes (2)

• AUCτ

  Area under the concentration-time curve from time zero to time τ

  0-12 hours after administration

• Cmax

  Maximum concentration of drug in plasma

  0-12 hours after administration

Study Arms (2)

BR6002A+BR6002B

ACTIVE COMPARATOR

Drug: BR6002A; Drug: BR6002B

BR6002

EXPERIMENTAL

Drug: BR6002

Interventions

BR6002A DRUG

One tablet administered alone

BR6002A+BR6002B

BR6002B DRUG

One tablet administered alone

BR6002A+BR6002B

BR6002 DRUG

One capsule administered alone

BR6002

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 30.0kg/m2 at screening visit.
• 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.

You may not qualify if:

• 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 1 month 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.
• In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Clinical Research Center, H PLUS Yangji Hospital

Seoul, Gwanakgu, 08779, South Korea

Location

MeSH Terms

Conditions

Duodenal Ulcer

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: July 14, 2023
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)