A Clinical Trial to Evaluate the Safety and Pharmacokinetic
Primary Purpose
Osteoporosis, Postmenopausal
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HUG186-B and HUG186-D
HUG186
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal
Eligibility Criteria
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
Sites / Locations
- Huons
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
HUG186-B and HUG186-D
HUG186
Arm Description
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
Outcomes
Primary Outcome Measures
AUC0-t of Bazedoxifene
Area under the curve(AUCt) of Bazedoxifene
Cmax of Bazedoxifene
Maximum observed concentration(Cmax) of Bazedoxifene
AUC0-t of Cholecalciferol
Area under the curve(AUCt) of Cholecalciferol
Cmax of Cholecalciferol
Maximum observed concentration(Cmax) of Cholecalciferol
Secondary Outcome Measures
Tmax of Bazedoxifene
Tmax of Bazedoxifene
AUCinf of Bazedoxifene
AUCinf of Bazedoxifene
t1/2 of Bazedoxifene
t1/2 of Bazedoxifene
Tmax of Cholecalciferol
Tmax of Cholecalciferol
AUCinf of Cholecalciferol
AUCinf of Cholecalciferol
t1/2 of Cholecalciferol
t1/2 of Cholecalciferol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03475719
Brief Title
A Clinical Trial to Evaluate the Safety and Pharmacokinetic
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
February 11, 2018 (Actual)
Study Completion Date
April 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huons Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
A randomized, open-label, single-dose, two-treatment, two-sequence, two-way crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HUG186-B and HUG186-D
Arm Type
Active Comparator
Arm Description
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
Arm Title
HUG186
Arm Type
Experimental
Arm Description
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
Intervention Type
Drug
Intervention Name(s)
HUG186-B and HUG186-D
Intervention Description
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
Intervention Type
Drug
Intervention Name(s)
HUG186
Intervention Description
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
Primary Outcome Measure Information:
Title
AUC0-t of Bazedoxifene
Description
Area under the curve(AUCt) 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)
Title
Cmax of Bazedoxifene
Description
Maximum observed concentration(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)
Title
AUC0-t of Cholecalciferol
Description
Area under the curve(AUCt) of Cholecalciferol
Time Frame
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Title
Cmax of Cholecalciferol
Description
Maximum observed concentration(Cmax) of Cholecalciferol
Time Frame
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Secondary Outcome Measure Information:
Title
Tmax of Bazedoxifene
Description
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)
Title
AUCinf of Bazedoxifene
Description
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)
Title
t1/2 of Bazedoxifene
Description
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)
Title
Tmax of Cholecalciferol
Description
Tmax of Cholecalciferol
Time Frame
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Title
AUCinf of Cholecalciferol
Description
AUCinf of Cholecalciferol
Time Frame
-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Title
t1/2 of Cholecalciferol
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Huons
City
Gyeonggi-do
State/Province
Seongnam-si
ZIP/Postal Code
13486
Country
Korea, Republic of
12. IPD Sharing Statement
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A Clinical Trial to Evaluate the Safety and Pharmacokinetic
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