骨質疏鬆症

本試驗之目的在研究健康成年受試者於空腹的情況下單劑量注射受試藥品TRIA11 (teriparatide 20 μg/80 μL)與對照藥品FORSTEO (teriparatide 20 μg/80 μL)之藥物動力學相等性，亦即評估此兩種藥品進入全身血液循環的速率與程度。

Teriparatide

20ug/80ul

本試驗係評估兩種teriparatide之藥物動力學相等性

Inclusion Criteria
(1)Age & Gender: Healthy adult male and female subjects between 18 and 55 years of age inclusive, at the time of signing the informed consent.
(2)Body weight ≥45 kg and body mass index (BMI) within the range 18.5 to 27 kg/m2.
(3)Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤1.5x upper limit of normal.
(4)Acceptable electrocardiogram (ECG) measurements. Average QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 msec.
(5)Female subjects of non-child bearing potential. Females of child bearing potential are eligible to enter if they are not pregnant and willing to practice an acceptable method of birth control for the duration of the study as judged by the investigator(s) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy performed on the subject).
(6)Healthy as determined by investigator(s), based on a medical evaluation.
(7)Capable of giving written informed consent.

Exclusion Criteria
(1)Subject with systolic blood pressure less than 90 mmHg or diastolic less than 60 mmHg irrespective of associated symptoms at the time of admission.
(2)If there is a drop in 20 mmHg of systolic pressure (and a 10 mmHg drop in diastolic) and a 20 beats per minute increase in heart rate between supine measurement and after two minutes standing at the time of admission.
(3)Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
(4)History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
(5)A clinically significant illness or surgery within four weeks prior to Period I dosing (as determined by the investigator).
(6)Evidence of chronic or acute infectious diseases.
(7)A positive pre-study drug/alcohol usage at the time of admission.
(8)Abuse of alcohol or drugs.
(9)Subjects with a history of scleroderma or any clinically significant dermatological condition or blemish at the injection site that the Investigator determines may adversely affect the injection or absorption of subcutaneously administered medications (e.g., psoriasis, scarring, tattoos, and birthmarks).
(10)Subjects with tattoos or birthmarks at the injection sites that are large enough to restrict injection site selection and/or evaluation.
(11)Subjects who are incapable of taking injections.
(12)Participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
(13) History of allergic response(s) to teriparatide or any other related drugs.
(14) Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within seven days (or 14 days if the drug is a potential enzyme inducer/inhibitor) or five half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and TSH Biopharm (TSH) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
(15)History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or TSH Medical Monitor, contraindicates their participation.
(16)Donation of more than 250 mL blood within two months prior to Period I dosing.
(17)The subject has a positive screen of hepatitis or human immunodeficiency virus (HIV) at the time of admission.
(18)Pregnant or lactating females.
(19)Unwillingness or inability to follow the procedures outlined in the protocol.
(20)Subject is mentally or legally incapacitated.
(21)Subjects who have asthma or a history of asthma including childhood asthma.
(22)Unable to refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice from seven days prior to the first dose.
(23)Any concern on the subject’s health conditions that investigators consider not suitable for study enrollment.

Inclusion Criteria
(1)Age & Gender: Healthy adult male and female subjects between 18 and 55 years of age inclusive, at the time of signing the informed consent.
(2)Body weight ≥45 kg and body mass index (BMI) within the range 18.5 to 27 kg/m2.
(3)Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤1.5x upper limit of normal.
(4)Acceptable electrocardiogram (ECG) measurements. Average QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 msec.
(5)Female subjects of non-child bearing potential. Females of child bearing potential are eligible to enter if they are not pregnant and willing to practice an acceptable method of birth control for the duration of the study as judged by the investigator(s) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy performed on the subject).
(6)Healthy as determined by investigator(s), based on a medical evaluation.
(7)Capable of giving written informed consent.

Exclusion Criteria
(1)Subject with systolic blood pressure less than 90 mmHg or diastolic less than 60 mmHg irrespective of associated symptoms at the time of admission.
(2)If there is a drop in 20 mmHg of systolic pressure (and a 10 mmHg drop in diastolic) and a 20 beats per minute increase in heart rate between supine measurement and after two minutes standing at the time of admission.
(3)Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
(4)History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
(5)A clinically significant illness or surgery within four weeks prior to Period I dosing (as determined by the investigator).
(6)Evidence of chronic or acute infectious diseases.
(7)A positive pre-study drug/alcohol usage at the time of admission.
(8)Abuse of alcohol or drugs.
(9)Subjects with a history of scleroderma or any clinically significant dermatological condition or blemish at the injection site that the Investigator determines may adversely affect the injection or absorption of subcutaneously administered medications (e.g., psoriasis, scarring, tattoos, and birthmarks).
(10)Subjects with tattoos or birthmarks at the injection sites that are large enough to restrict injection site selection and/or evaluation.
(11)Subjects who are incapable of taking injections.
(12)Participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
(13) History of allergic response(s) to teriparatide or any other related drugs.
(14) Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within seven days (or 14 days if the drug is a potential enzyme inducer/inhibitor) or five half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and TSH Biopharm (TSH) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
(15)History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or TSH Medical Monitor, contraindicates their participation.
(16)Donation of more than 250 mL blood within two months prior to Period I dosing.
(17)The subject has a positive screen of hepatitis or human immunodeficiency virus (HIV) at the time of admission.
(18)Pregnant or lactating females.
(19)Unwillingness or inability to follow the procedures outlined in the protocol.
(20)Subject is mentally or legally incapacitated.
(21)Subjects who have asthma or a history of asthma including childhood asthma.
(22)Unable to refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice from seven days prior to the first dose.
(23)Any concern on the subject’s health conditions that investigators consider not suitable for study enrollment.