A double blind single-dose study to evaluate pharmacokinetics, safety and tolerability of Stelis Teriparatide [rh-PTH (1-34)] with innovator product Forsteo Registered Trademark (European Innovator) in healthy volunteers via subcutaneous administration of a single dose of 20 mcg .

Exclusion Criteria21

• Known history of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus [test for hepatitis C virus antibody (HCV Ab)] or hepatitis B virus [test for hepatitis B surface antigen (HBsAg)].
• History of severe allergic reactions to any drug or anaphylactic reactions.
• Known allergy to Teriparatide or any other components of the product (both Test & Reference products).
• Subjects with a history of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamos cell carcinomas of the skin that have been completely excised and are considered cured).
• Has undergone major surgery within the previous 12 months from screening visit or is planning to undergo a major surgery within 12 weeks of screening visit.
• Female subjects who are pregnant or have a positive pregnancy test result currently breastfeeding, or planning to become pregnant during the course of the study.
• Vaccinations within 4 weeks, prior to study medicine administration in period 1.
• Blood donation (Greater than equal to 500 mL) within 30 days prior to screening.
• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
• History of alcohol or substance abuse.
• Positive result for drugs of abuse on admission to the study center including amphetamines, barbiturates, cocaine, methadone, 3, 4 methylenedioxymethamphetamine (ecstasy), phencyclidine, tetrahydrocannabinol, and opiates.
• Use of any tobacco product more than 5 times within 30 days prior to screening.
• Positive testing for alcohol at check-in.
• Alcohol use within 72 hours prior to dosing of period 01. Subjects must be willing to restrict alcohol use throughout their participation in the study.
• Clinically significant abnormal clinical laboratory test values, as determined by the Investigator, or any values for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine that are above the upper limit of normal, any values for platelets or hemoglobin that are below the lower limit of normal, or any out of normal range values for white blood cells, serum sodium, or serum potassium or as determined by the Investigator,
• Clinically significant abnormalities in 12-lead ECG.
• Any previous treatment with any parathormone/teriparatide product, including investigational use.
• Prior treatment with any investigational drug within the 30 days prior to Day 1, or within 5 half-lives of the drug, whichever is longer.
• Treatment with any medication prescribed within 30 days prior to Day 1 or longer if the medication has a long half-life, and over-the-counter (OTC) products including analgesics, herbal remedies, vitamin therapy within 14 days prior to Day 1 or longer if the medication has a long half-life, unless agreed as not clinically significant by the Investigator (vitamins, minerals, and nutrition supplements may be taken at the discretion of the Investigator). Exception: contraceptives.
• Inability to comply with study requirements.
• Other unspecified reasons that, in the opinion of the Investigator or sponsor, make the subject unsuitable for enrollment.