CTRI/2024/07/070445尚未招募不适用
A PHASE - 1, OPEN-LABEL, NON-RANDOMIZED, MULTIPLE-DOSE, TWO-TREATMENT, SINGLE SEQUENCE, DRUG-DRUG INTERACTION STUDY TO ASSESS PHARMACOKINETICS (PK), PHARMACODYNAMICS (PD), SAFETY, AND TOLERABILITY OF AN ORAL CONTRACEPTIVE CONTAINING ETHINYL ESTRADIOL (EE) 0.03 MG AND LEVONORGESTREL (LNG) 0.15 MG TABLET WHEN ADMINISTERED ALONE AND IN COMBINATION WITH HRF-10071 TABLET 120 MG IN HEALTHY, ADULT, HUMAN FEMALE SUBJECTS UNDER FASTING CONDITION.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Ct,ss, Cmax,ss, AUC0-t,ss
研究概览
简要总结
This is a phase-I, open-label, non-randomized, multiple-dose, two treatment, single sequence, drug-drug interaction study to assess pharmacokinetics (pk), pharmacodynamics (pd), safety, and tolerability which will be conducted in normal healthy adult female volunteers under fasting condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •a) Non-smoking, nonalcoholic, healthy adult human female participants between 18 to 45 years of age (both inclusive).
- •b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg / height in meter2 and weight not less than 50.00 Kg. c) Not having any significant disease in medical history or clinically significant abnormal findings during screening, clinical examination, Gynecological examination (including pelvic examination and routine breast examination), laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
- •d) Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- •e) Literate and able to give voluntary written informed consent for participation in the trial.
- •f) Pap smear and USG Pelvic should be clinically acceptable.
- •g) Serum Estradiol level should be clinically acceptable.
- •a) Surgically sterilized (bilateral tubal ligation, or hysterectomy has been performed on the participant) at least 6 months prior to study participation OR If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method (abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam) or non-hormonal intra uterine device during the study and for 14 days after last dose.
- •and Serum Pregnancy test at screening and prior to check-in of Period-I must be negative.
排除标准
- •a) Known hypersensitivity or idiosyncratic reaction to Ethinyl Estradiol and Levonorgestrel or normally used medicines such as anti-histamines, NSAIDs or any of the excipients or related drug.
- •b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •c) Ingestion of a medicine (any prescribed medications or OTC medications, herbal products including traditional herbal remedies (e.g., Ayurveda, Unani, Traditional Chinese medicines St. John’s wort etc.), and homeopathic products, CYP inducers or inhibitors) at any time within 30 days prior to first IMP administration of Period-I and any vaccine (including COVID-19 vaccine) from 30 days prior to first dosing of period-I.
- •In any such case participant selection will be at the discretion of the Principal Investigator.
- •d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- •e) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •f) consumption of alcohol or alcoholic products within 48 hours prior to first IMP administration.
- •g) Smokers, or who have smoked within last six months prior to start of the study h) History past or presence suggestive of gastric and/or duodenal ulceration.
- •i) History past or presence suggestive of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •j) The presence of clinically significant abnormal laboratory values during screening.
- •k) History or presence of seizure or psychiatric disorders.
- •l) A history of difficulty in donating blood.
- •m) History past or presence suggestive of cancer.
- •n) Difficulty in swallowing tablet/capsule.
- •o) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- •p) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of investigational medicinal product received.
- •q) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- •r) A positive test result for HIV (1 and/or 2) antibody t) Any Grade 2 to 4 laboratory abnormality as per CTCAE grading at Screening, with the exception of lipid abnormalities (e.g., total cholesterol, triglycerides) and ALT/AST (described above), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor.
- •A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.
- •u) Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the investigator will interfere with the safety for the individual participant.
- •v) Consumption of Grapefruits or Grapefruit products within 72 hours prior to first IMP administration.
- •w) An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to first IMP administration.
- •x) History or presence of significant easy bruising or bleeding y) History or presence of significant recent trauma.
- •z) History of thromboembolic disease.
- •aa) Nursing mothers.
结局指标
主要结局
Ct,ss, Cmax,ss, AUC0-t,ss
时间窗: 0.000, 0.250, 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, 7.000, 8.000, 10.000, 12.000 and 24.000, 48.000 and 72.000
次要结局
- Tmax,ss, t1/2(0.000, 0.250, 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, 7.000, 8.000, 10.000, 12.000 and 24.000, 48.000 and 72.000)
研究者
Dr Dwarkesh Oswal
Lambda Therapeutic Research Ltd
研究点 (1)
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