A Clinical Trial to Evaluate the Safety and Pharmacokinetic

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03475719
• Other study ID #: HUG186_P1
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: January 11, 2018
• Last updated: March 16, 2018
• Start date: January 11, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: March 2018
• Source: Huons Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 52
• Est. completion date: April 30, 2018
• Est. primary completion date: February 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• HUG186-B and HUG186-D
Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
• HUG186
Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)

Locations

Country	Name	City	State
Korea, Republic of	Huons	Gyeonggi-do	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Tmax of Bazedoxifene	Tmax of Bazedoxifene	0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Secondary	AUCinf of Bazedoxifene	AUCinf of Bazedoxifene	0, 0.17, 0.33, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h(17points)
Secondary	t1/2 of Bazedoxifene	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)
Secondary	Tmax of Cholecalciferol	Tmax of Cholecalciferol	-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Secondary	AUCinf of Cholecalciferol	AUCinf of Cholecalciferol	-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)
Secondary	t1/2 of Cholecalciferol	t1/2 of Cholecalciferol	-24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h(18points)