None listed
Conditions
Interventions
Drug : 1. Test drug
Code name : Rap18001
Frequency & Duration : Single transdermal
Dosage : 1 ea
2. Comparator
Code name : Teribone Inj. 56.5ug
Frequency & Duration : Single subcutaneous
Dosage
Sponsors
Chonbuk National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy woman and age 50 years or more and naural monopause for 1year or more or surgical menopause at the time of screening 2. Body mass index(BMI) more than 17.5kg / m2 and less than 30.5kg / m2 and weight more than 45kg 3. Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as electrocardiography(ECG) test. 4. Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital Institutional Review Board(IRB). 5. Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
Exclusion criteria
Exclusion criteria: 1. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results 2. Those who show the following figures as a result of laboratory tests ? ALT or AST> 2 times upper limit of normal range ? ALP> 2 times upper limit of normal range ? Total calcium> 1.5 times upper limit of normal range 3. Patients with Pager's disease 4. Patients who had been undergone radiation therapy for bones 5. Patients with primary malignant bone tumors or metastatic bone tumor 6. Patients with metabolic bone disease except Osteoporosis (hyperparathyroidism etc.) 7. Patients with a history of hypersensitivity to the test drug or the components of the test drug 8. When the left-sided blood pressure is more than 150 mmHg or less thean 100mmHg (systolic blood pressure) or more than 100 mmHg or less then 60 mmHg (diastolic blood pressure) 9. Patients with severe renal impairment (eGFR<30 ml/min/1.73m2) 10. Patients with severe heart disease 11. Patients with severe hepatic impairment 12. Patients with urinary stone 13. History of significant alcohol abuse or drug abuse within one year prior to the Screening 14. Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing 15. Subjects who treated with digitalis or activated vitamin D (alfacalcidol, calcitriol, eldecalcitol, maxacalcitol, falecalcitriol)within 10days prior to the first dosing 16. Alcohol > 210g/week, within 6 months prior to the screening 17. Smoker (= 20cigarettes/day), within 6 months prior to the screening 18. Subject who done the whole blood donation within two months or component blood donation within 1 month prior to the first dosing 19. Subject who has participated in any other clinical trials or bioequivalence study and has had medication within 6 months prior to the day of the first administration of investigational product 20. Subjects who is determined by investigator's decision as unsuitable for clinical trial participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt, AUCinf, Cmax, Tmax, t1/2 of Teriparatide | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf, Tmax, t1/2 of Teriparatide | — |
Countries
Korea, Republic of
Contacts
Public ContactJi jeon
Chonbuk National University Hospital
Outcome results
None listed