A Study of INTG8 in Healthy Men and Postmenopausal Wome
- Registration Number
- CTRI/2018/09/015697
- Lead Sponsor
- INTAS PHARMACEUTICALS LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 meter square
3. Postmenopausal women with serum FSH levels greater than 40 mIU per mL: Postmenopausal women includes 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).
1. Known hypersensitivity or idiosyncratic reaction to teriparatide or any related drug.
2. Subjects with known latex allergies.
3. Subjects will be 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 of standing when compared with blood pressure from sitting or supine position) 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 7 standard drinks per week (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.
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 only) 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.
16. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
17. A positive test result for HIV(I and II) antibody.
18. Consumption of grape fruit or grape fruit products within 72 hours prior to dosing.
19. Male subject with hemoglobin level less than 11.1 gm/dL and female subjects with hemoglobin level less than 10 gm/dL.
20. Subjects with abnormal PTH level, i.e., PTH level less than 15 pg/mL or greater than 65 pg/mL.
21. An unusual diet (e.g., low-sodium) for 4 weeks prior to receiving the study medicine. In any such case, subject selection will be at the
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic bioequivalence of INTG8 of Intas Pharmaceuticals Limited, India against Forteo (Lilly USA, LLC) and Forsteo (ELI LILLY NEDERLAND B.V., THE NETHERLANDS)Timepoint: (0.000 and at 0.083, 0.167, 0.250, 0.333, 0.500, 0.750, 1.000, 1.333, 1.667, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000 hour post dose
- Secondary Outcome Measures
Name Time Method -Assessment and comparision of local tolerance, safety and tolerability of INTG8 of Intas Pharmaceuticals Limited, India against Forteo (Lilly USA, LLC) and Forsteo (ELI LILLY NEDERLAND B.V., THE NETHERLANDS) <br/ ><br> <br/ ><br>-Assessment and comparision of pharmacodynamics of INTG8 of Intas Pharmaceuticals Limited, India against Forteo (Lilly USA, LLC) and Forsteo (ELI LILLY NEDERLAND B.V., THE NETHERLANDS)Timepoint: At screening, After check-in, Before check-out, 28 days after dosing of Period III <br/ ><br> <br/ ><br> <br/ ><br>0.000 and at 0.500, 1.000, 2.000, 3.000, 4.000, 5.000, 6.000, 8.000, 12.000, 16.000 and 24.000 hour post dose