Overview

A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.

Status:
Completed
Trial end date:
2020-08-26
Target enrollment:
0
Participant gender:
Male
Summary
To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and tolerability when administered separately or co-administered to healthy male volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Treatments:
Mirabegron
Tamsulosin
Criteria
Inclusion Criteria:

1. Subjects are given sufficient explanations about the trial objectives and contents as
well as properties of investigational drugs before participating in the trial, and
will voluntarily express their consent by signing an IRB-approved written consent to
participate in the trial.

2. Healthy male adults aged 19 to 55 years at screening.

3. The subject's weight is 50kg or more and body mass index (BMI) is 18.0 or more but
30.0 or less.

Exclusion Criteria:

1. Those who have history of clinically significant diseases including hypersensitivity
reaction, intolerability and anaphylaxis to major ingredients (Tamsulosin and
Mirabegron) and other ingredients of investigational products, Food Yellow No. 5
(Sunset Yellow FCF) or Sulfonamide.

2. Those who have a history of clinically significant diseases related to liver, kidney,
digestive system, respiratory system, musculoskeletal system, endocrine system,
neuropsychiatric system, hemato-oncology system, cardiovascular system (including
orthostatic hypotension), etc.

3. Those who have medical history of gastrointestinal system diseases (for example:
Crohn's disease, peptic ulcer disease, etc.) and operations that may influence the
absorption of investigational drugs. (However, appendectomy, hernia operation,
endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are
excluded.)

4. Those with abnormal findings from the screening tests (medical interview, vital signs,
electrocardiography, physical checkup, blood test, urinalysis, etc.) are judged to
have clinical significance.

5. Those who are positive to HBsAg, HCV Ab, HIV Ab, VDRL tests at screening.

6. Those with any of the following results at screening:

- AST or ALT > twice the upper limit of normal range

- T. bilirubin > twice the upper limit of normal range

- Estimated glomerular filtration rate (e-GFR) < 60 mL/min/1.73m2 (MDRD method
used)

7. Those with systolic blood pressure > 150 mmHg or < 90 mmHg, or diastolic blood
pressure > 95 mmHg or < 60 mmHg from vital signs at screening.

8. Those who took drugs (prescription drugs, OTC, herbal medicine or nutritional
supplements (vitamins, etc.)) 2 weeks before screening. (However, those may
participate in the trial if their safety and study results are considered to be
unaffected according to the investigator's judgment.)

9. Those who have a drug abuse problem (especially centrally acting drugs including
sleeping pills, centrally acting pain reliever, opiates or psychoactive drugs) or have
a history of drug abuse.

10. Those who have a history of continuous alcohol intake exceeding 21 units/week
(1unit=10g=12.5mL) within 6 months before screening.

11. Those who have smoked more than 10 cigarettes a day within 6 months before screening.

12. Those who have participated in other clinical trials and have been administered with
other investigational drugs 180 days prior to the estimated administration date of
this study's investigational drugs (However, is not applicable if the investigational
drugs from other trials are not administered).

13. Those who have given whole blood 8 weeks before screening, who have given
plasma/platelet 4 weeks before screening or who have not expressed their consent for
blood-donation prohibition between the period from the first administration and 30
days after the final administration of the investigational drugs.

14. Those who have not expressed their consent for diet restrictions (grapefruit, caffeine
in particular) that can influence absorption, distribution, metabolism and excretion
of investigational drugs in the period between 3 days before the first administration
and the last visit.

15. Those who have not expressed their consent for using contraceptive measures (for
example: contraceptive administration and implant or intrauterine devices,
sterilization (vasectomy, tubal ligation, etc.)) and barrier methods (combined use of
spermicides and condom, contraceptive vaginal diaphragm, contraceptive sponge or
cervical cap) that are allowed for clinical trials in the period between the first
administration of the investigational drugs and the last visit.

16. Others who are judged to be ineligible to participate in the trial by the
investigator.