None listed
Conditions
Interventions
Intervention1: r-hFSH (Recombinant Human Follicle Stimulating Hormone injection), Solution for Injection: Pre-filled pen containing follitropin alfa 300 IU (equivalent to 22 mcg) to be used for the tr
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a) Non smoker, normal, healthy, adult, human female volunteers (FSH level less than or equal to 25 mIU per mL) between 18 to 45 years of age (both inclusive) and having regular menstrual cycles of 25 to 34 days before initiation of Leuprolide acetate. b) Having a Body Mass Index (BMI) between 18.5 to 30.0 (both inclusive), calculated as weight in kg per height in m2. c) Not having any significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, Gynecological examination (including pelvic examination and routine breast examination), laboratory evaluations, Pelvic USG, 12-lead ECG and X-ray chest (Postero-anterior view) recordings. d) Able to understand and comply with the study procedures, in the opinion of the investigator. e) Able to give voluntary written informed consent for participation in the trial. f) Pap smear report should be negative. g) If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra uterine device during the study and for 30 days after completion of the study. h) Serum pregnancy test must be negative at the time of screening.
Exclusion criteria
Exclusion criteria: a) Known hypersensitivity or idiosyncratic reaction to r-hFSH or Leuprolide Acetate or desogestrel or ethinyl estradiol any of the formulation excipients or any related drug. b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, neurological, psychiatric, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. c) Ingestion of a medication (prescribed & over the counter (OTC) medication including herbal remedies (other than the provided oral contraceptive)) at any time within 14 days before Leuprolide acetate administration of period-I and any vaccine (including COVID-19 vaccine) from 14 days prior to Leuprolide acetate dosing of period I and depot injection or implant within 3 months prior to Leuprolide acetate dosing in period I. In any such case subject selection will be at the discretion of the Principal Investigator or designee. d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria. e) Consumption of Grapefruits or grapefruit products within a period of 72 hours prior to first r-hFSH administration in period-I. f) The presence of clinically significant abnormal laboratory values during screening. g) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. h) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 07 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to first r-hFSH administration in period-I. i) Smokers or who have smoked within last 06 months prior to start of the study. j) A history of difficulty in donating blood. k) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dosing of study medication. l) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to first dosing of study medication. If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received. m) A positive hepatitis screen including hepatitis B surface antigen and or HCV antibodies. n) A positive test result for HIV (1 and or 2) antibody. o) History or presence of seizure or psychiatric disorders. p) An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to first r-hFSH administration in period-I. In any such case subject selection will be at the discretion of the Principal Investigator or designee. q) Difficulty in swallowing solid oral dosage form like tablet or capsule. r) Nursing mothers. s) Undiagnosed vaginal bleeding and having irregular menstrual cycles. t) Abnormal Pelvic USG examination. u) Any clinically significant abnormal pelvic ultrasound scan results found during medical screening. v) Subject with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. w) Abnormal Pap smear prior to administration of Leuprolide acetate. <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor’s Test Product relative to that of Reference Product after single subcutaneous dose administration in pituitary down-regulated normal, healthy, adult, human female subjects under fasting conditions and to assess the bioequivalenceTimepoint: Pre-dose (-1.000, -0.500, 0.000) and at 2.000, 4.000, 6.000, 8.000, 12.000, 16.000, 18.000, 20.000, 22.000, 24.000, 28.000, 32.000, 36.000, 42.000, 48.000, 60.000, 72.000, 96.000, 120.000, 144.000 and 192.000 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess pharmacodynamic parameters - serum estradiol (E2) 2) To assess immunogenicity Incidence of ADA & NAb, ADA titre 3) To monitor the adverse events & to ensure the safety of the subjects 4) To assess the tolerability (local & systemic tolerability) of recombinant human follicle stimulating hormone (r-hFSH) of Intas Pharmaceuticals Ltd in comparison with Gonal-FA Recombinant human follicle stimulating hormone (r-hFSH) follitropin alfa, solution for injection of Merck Serono Limited Timepoint: Pre-dose (-1.000, -0.500, 0.000) & at 2.000, 4.000, 6.000, 8.000, 12.000, 16.000, 18.000, 20.000, 22.000, 24.000, 28.000, 32.000, 36.000, 42.000, 48.000, 60.000, 72.000, 96.000, 120.000, 144.000 & 192.000 hours | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed