Essential Hypertension
Conditions
Brief summary
The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015 and co-administration of BR1015-3 and BR1015-2 in healthy volunteers under fed conditions
Interventions
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Those 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. * Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagrees to provide their sperm or ovum. * Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
Exclusion criteria
* 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 have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery) * Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration. * In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from time zero to time τ | 0-72 hours after administration |
| Maximum concentration of drug in plasma | 0-72 hours after administration |
Countries
South Korea
Outcome results
None listed