NCT06184269CompletedPhase 1
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B"
An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 4-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1017-1" and Co-administration of "BR1017-1A" and "BR1017-1B" in Healthy Volunteers
Source: ClinicalTrials.gov · Last updated 2 Apr 2024
Brief summary (registry, in English)
The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1017-1" and co-administration of "BR1017-1A" and "BR1017-1B" in healthy volunteers
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 14 Dec 2023
- Start date
- 23 Dec 2023
- Primary completion date
- 18 Feb 2024
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- NCT number
- NCT06184269
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 58
- From 23 Dec 2023 to the primary completion date, 18 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs 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, etc.)
- Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
- Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
Other illness
- Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
Other
- In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Who the study is looking for
- Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
- 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.
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Center, H PLUS Yangji Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.