CTRI/2025/01/079588尚未招募不适用
An open label, phase-I, balanced, randomized, two-treatment, two-period, two-sequence, single subcutaneous dose administration, crossover, bioequivalence study of r-hFSH (Recombinant human follicle stimulating hormone injection), solution for injection of Intas pharmaceuticals limited, India with GONAL-F, Recombinant human follicle stimulating hormone (r-hFSH) follitropin alfa, solution for injection of Merck serono Ltd. in pituitary down-regulated normal, healthy, adult, human female subjects under fasting conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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 bioequivalence
研究概览
简要总结
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsoras 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 bioequivalence
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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 m
- •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.
排除标准
- •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.
- •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.
- •w) Abnormal Pap smear prior to administration of Leuprolide acetate.
结局指标
主要结局
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 bioequivalence
时间窗: 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
次要结局
- 1) To assess pharmacodynamic parameters - serum estradiol (E2)(2) To assess immunogenicity Incidence of ADA & NAb, ADA titre)
研究者
Dr Dwarkesh Oswal
Lambda Therapeutic Research Ltd
研究点 (1)
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