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Completed

NCT Number: NCT05959499

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

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

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Center, H PLUS Yangji Hospital

Seoul, Gwanakgu, 08779, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BR6002A

Drug

One tablet administered alone

BR6002B

Drug

One tablet administered alone

BR6002

Drug

One capsule administered alone

Primary outcomes

  1. AUCτ

    Time frame: 0-24 hours after administration

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

  2. Cmax

    Time frame: 0-24 hours after administration

    Maximum concentration of drug in plasma

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

An Open-label, Randomized, Fed, Single-dose, 2-sequence, 4-period, Full Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" in Healthy Adult Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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