A Clinical Trial to Evaluate the Safety and Pharmacokinetic

NCT03475719 | Unknown Phase 1

• 1 other identifier: HUG186_P1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (4)

• AUC0-t of Bazedoxifene

  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

  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

  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

  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 Outcomes (6)

• 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

  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

  -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)

Study Arms (2)

HUG186-B and HUG186-D

ACTIVE COMPARATOR

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

Drug: HUG186-B and HUG186-D

HUG186

EXPERIMENTAL

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

Drug: HUG186

Interventions

HUG186-B and HUG186-D DRUG

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

HUG186-B and HUG186-D

HUG186 DRUG

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

HUG186

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Huons

Gyeonggi-do, Seongnam-si, 13486, South Korea

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, open-label, single-dose, two-treatment, two-sequence, two-way crossover study

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: March 23, 2018
• Study Start: January 11, 2018
• Primary Completion: February 11, 2018
• Study Completion: April 30, 2018
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

KR (1)