None listed
Conditions
Interventions
Intervention1: Teriparatide 20 microgram/80 microlitre recombinant human parathyroid hormone Injection: Dose: 20 microgram once daily,
Manufacturer: Intas Pharmaceuticals Limited, India,
Pharmaceutic
Marketing authorization holder: Eli Lilly Nederland B.V., The Netherland.
Pharmaceutical form: Solution for injection in pen device
Route of administration: Subcutaneous
Control Intervention2: Reference Product- R2: Forteo® Teriparatide 20 microgram Injection: Dose: 20 microgram once daily
Marketing authorization holder: Lilly USA, LLC
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-smokers, Non-tobacco users, normal, healthy, adult, human male subjects between 18 and 45 years of age (both inclusive) and postmenopausal women subjects between 45 and 65 years of age (both inclusive). 2. Having a Body Mass Index (BMI) between 18.5 to 30 (both inclusive), calculated as weight in kg per height in m2. 3. Postmenopausal women with serum FSH levels greater than 40 mIU per mL: Postmenopausal women include women with 6 months of spontaneous amenorrhea OR 6-week post-surgical bilateral oophorectomy with or without hysterectomy prior to the start of the study (Investigator may request the official report to confirm the surgery date and exclude cancer as the cause needing surgery). 4. Able to comply with the study procedures, in the opinion of the Principal Investigator. 5. Able to give voluntary written informed consent for participation in the trial. 6. Serum pregnancy test at the time of screening must be negative (for females).
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or idiosyncratic reaction to Teriparatide its ingredients (glacial acetic acid, sodium acetate, mannitol, metacresol, hydrochloric acid, sodium hydroxide solution) or any related drug. 2. Subjects with known latex allergies. 3. Subjects assessed for orthostatic hypotension (Defined as decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes in standing position when compared with blood pressure from sitting or supine position with clinical symptoms) and confirmed unsafe for study inclusion by the investigator. 4. Subjects with systemic hypotension (Below 90 mm Hg systolic blood pressure in sitting position) and considered unfit for trial by the investigator. 5. History or presence of any disease or disorder known to influence bone metabolism, compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. 6. History or presence of metabolic bone disease, active or recent urolithiasis, hypercalcemia and hypercalcaemic disorders, osteosarcoma or Pagetâ??s disease of bone, prior external beam or implant radiation therapy involving the skeleton. 7. Subjects with history of ingestion of medicine (including herbal remedies) at any time within 14 days prior to dosing in period-I. In any such case, subject selection will be at the discretion of the Principal Investigator. 8. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAID induced urticaria. 9. A recent history of harmful use of alcohol (less than 2 years), i.e., alcohol consumption of more than 14 standard drinks for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40 percentage distilled spirits, such as rum, whisky, brandy, etc.) or Consumption of alcohol or alcoholic products within 48 hours prior to receiving the study drug in period-I. 10. Smokers or tobacco users, who consumed tobacco or tobacco-containing products (gutkha, pan/pan masala, beedi, cigarettes, others) within 6 months prior to start of the study or has inability to abstain from smoking during the study period. 11. Having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG, Abdominal-pelvis ultrasonography (for females) and X-ray chest (postero-anterior view) recordings. 12. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. 13. History or presence of psychiatric disorders. 14. A history of difficulty with donating blood. 15. Donation of blood (1 unit or 350 mL) or receipt of an investigational drug or product or participation in a drug research study within 6 months prior to receiving the first dose of the study medicine (or longer as per local regulatory requirement). 16. A positive hepatitis screen including hepatitis B surface antigen and or or HCV antibodies. 17. A positive test result for HIV (1 and/ or 2) antibody. 18. Consumption of grapefruit or grapefruit products within 72 hours prior to dosing in period-I. 19. Male subject with hemoglobin level less than 11.1 gm per dL and female subjects with hemoglobin level less than
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate pharmacokinetic bioequivalence of INTG8 of Intas Pharmaceuticals Limited, India against Forteo® (Lilly USA, LLC) and Forsteo® (ELI LILLY NEDERLAND B.V., THE NETHERLANDS) following 20 microgram single subcutaneous injection in healthy men and postmenopausal women.Timepoint: PK- Pre-dose and at 0.083, 0.167, 0.25, 0.333, 0.5, 0.75, 1.0, 1.25, 1.50, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0 and 4.5 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess and compare local tolerance, safety and tolerability of INTG8 of Intas Pharmaceuticals Limited, India against Forteo® and Forsteo® following 20 microgram single subcutaneous injection in healthy men and postmenopausal women. 2. To assess and compare pharmacodynamics of INTG8 of Intas Pharmaceuticals Limited, India against Forteo® and Forsteo® following 20 microgram single subcutaneous injection in healthy men and postmenopausal women Timepoint: PD- Pre-dose and at 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0, 16.0 and 24.0 hrs | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed