CClinicalTrials.gg
Status unknownNCT03475719Updated Mar 23, 2018

A Clinical Trial to Evaluate the Safety and Pharmacokinetic

A Phase 1 interventional study of HUG186-B and HUG186-D and HUG186 in Osteoporosis, Postmenopausal, sponsored by Huons Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-23.

Sponsored by Huons Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Osteoporosis, Postmenopausal
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.
  2. Body weight of ≥ 55 kg, BMI 18.5 to 30.0
  3. No morbid symptom or sign, based on physical examination, with no innate or chronic disease.
  4. 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.
  5. Subject that agree to apply sun cream in case of daylight exposure for more than 1hours
  6. 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

Exclusion Criteria:

  1. 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.
  2. A history of hypersensitivity to investigational drugs and its additives or clinically significant hypersensitivity to any other drug.
  3. History of drug abuse, or positive in drug screening test.
  4. Use of inducer or inhibitor of metabolic enzymes for drugs like barbiturate.
  5. 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.
  6. 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)
  7. 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.
  8. 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.
  9. Smoking more than 10 cigarettes per day, excessive caffeine consumption (example: instant coffee > 5 cups/day)
  10. Subjects who are judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    HUG186-B and HUG186-D

    Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)

    Drug: HUG186-B and HUG186-D

  • Experimental
    HUG186

    Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)

    Drug: HUG186

Interventions

  • DrugHUG186-B and HUG186-D

    Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)

  • DrugHUG186

    Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)

05

What researchers measure

Primary outcomes

  1. AUC0-t of Bazedoxifene

    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)

  2. Cmax of Bazedoxifene

    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)

  3. AUC0-t of Cholecalciferol

    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)

  4. Cmax of Cholecalciferol

    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 outcomes

  1. Tmax of Bazedoxifene

    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)

  2. AUCinf of Bazedoxifene

    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)

  3. t1/2 of Bazedoxifene

    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)

  4. Tmax of Cholecalciferol

    Tmax of Cholecalciferol

    Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)

  5. AUCinf of Cholecalciferol

    AUCinf of Cholecalciferol

    Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)

  6. t1/2 of Cholecalciferol

    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)

06

Study locations

1 site
  • Huons
    Gyeonggi-do, Seongnam-si 13486, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03475719
Lead sponsor
Huons Co., Ltd.
Responsible party
Sponsor
First posted
Mar 23, 2018
Start date
Jan 11, 2018
Primary completion
Feb 11, 2018
Completion
Apr 30, 2018 (estimated)
Last update
Mar 23, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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