- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03475719
A Clinical Trial to Evaluate the Safety and Pharmacokinetic
March 16, 2018 updated by: Huons Co., Ltd.
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristic After Administration of Fixed-dose Combination or Loose Combination of HUG186 in Healthy Adult Male or Menopausal Female Volunteers
A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seongnam-si
-
Gyeonggi-do, Seongnam-si, Korea, Republic of, 13486
- Huons
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Men, age≥19 years of age, Postmenopausal women are eligible. Postmenopausal is defined as any of the following:
- Amenorrhea for 12 or more months
- FSH and estradiol in the postmenopausal range per local normal range.
- Body weight of ≥ 55 kg, BMI 18.5 to 30.0
- No morbid symptom or sign, based on physical examination, with no innate or chronic disease.
- Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis) that is performed according to the characteristics of investigational drugs.
- Subject that agree to apply sun cream in case of daylight exposure for more than 1hours
- Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent.
Exclusion Criteria:
- A clinically significant disease or history in hepatobiliary system, kidney, digestive system, respiratory system, hemato-oncological system, endocrine system, neuro-psychiatric system, musculo-skeletal system, immune system, otorhinolaryngological system or cardiovascular system.
- A history of hypersensitivity to investigational drugs and its additives or clinically significant hypersensitivity to any other drug.
- History of drug abuse, or positive in drug screening test.
- Use of inducer or inhibitor of metabolic enzymes for drugs like barbiturate.
- Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of investigational drug, and this will affect this study or the safety of the subjects at discretion of study investigator.
- Participation in another clinical trial or a bioequivalent study within 3 months prior to the first administration of investigational drug (The finish time of previous study is the day of the last administration of study drug)
- Whole blood donation within 2 months or component donation within 1 month, prior to the first administration of investigational drug, or transfusion within 1 month prior to the first administration of investigational drug.
- Prolonged excessive alcohol consumption (>21 units/week, 1 unit=10g of pure alcohol), or subjects who can not abstain from drinking from 24 hours prior to hospitalization until the discharge.
- Smoking more than 10 cigarettes per day, excessive caffeine consumption (example: instant coffee > 5 cups/day)
- Subjects who are judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: HUG186-B and HUG186-D
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
|
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
|
EXPERIMENTAL: HUG186
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
|
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-t of Bazedoxifene
Time Frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
Area under the curve(AUCt) of Bazedoxifene
|
0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
Cmax of Bazedoxifene
Time Frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
Maximum observed concentration(Cmax) of Bazedoxifene
|
0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
AUC0-t of Cholecalciferol
Time Frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
Area under the curve(AUCt) of Cholecalciferol
|
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
Cmax of Cholecalciferol
Time Frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
Maximum observed concentration(Cmax) of Cholecalciferol
|
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax of Bazedoxifene
Time Frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
Tmax of Bazedoxifene
|
0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
AUCinf of Bazedoxifene
Time Frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
AUCinf of Bazedoxifene
|
0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
t1/2 of Bazedoxifene
Time Frame: 0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
t1/2 of Bazedoxifene
|
0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
|
Tmax of Cholecalciferol
Time Frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
Tmax of Cholecalciferol
|
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
AUCinf of Cholecalciferol
Time Frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
AUCinf of Cholecalciferol
|
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
t1/2 of Cholecalciferol
Time Frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
t1/2 of Cholecalciferol
|
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 11, 2018
Primary Completion (ACTUAL)
February 11, 2018
Study Completion (ANTICIPATED)
April 30, 2018
Study Registration Dates
First Submitted
January 11, 2018
First Submitted That Met QC Criteria
March 16, 2018
First Posted (ACTUAL)
March 23, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 23, 2018
Last Update Submitted That Met QC Criteria
March 16, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUG186_P1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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