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A Clinical Trial to Evaluate the Safety and Pharmacokinetic | Clinical Trials | Clareo Health

UNKNOWNPHASE1

A Clinical Trial to Evaluate the Safety and Pharmacokinetic

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

NCT03475719•Huons Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

19 - No limit years

Sex

ALL

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

•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

Locations (1)

Huons

Gyeonggi-do, Seongnam-si, South Korea

Key Dates

Start Date

January 11, 2018

Primary Completion Date

February 11, 2018

Completion Date

April 30, 2018

Last Updated

March 23, 2018

Enrollment

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

HUG186-B and HUG186-D

DRUG

HUG186

DRUG

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

View study

RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

View study

WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial to Evaluate the Safety and Pharmacokinetic

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects