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. - NI

Hetero Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

阶段: Unknown
状态: 尚未招募
发起方: Hetero Labs Limited

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

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
•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.
•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

研究者

发起方

Hetero Labs Limited

相似试验

已完成

1 期

A PHASE 1 CLINICAL TRIAL, TO DETERMINE THE MAXIMUM TOLERATED DOSE AND THE DOSE LIMITING TOXICITY OF A NEW DRUG GENOPEP 1 (ISSAR 1) IN RELAPSED SOLID TUMOUR CANCER PATIENTS

CTRI/2010/091/000200ISSAR Pharmaceuticals Pvt Ltd160

撤回

不适用

A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-PF-06835919 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06835919 IN HEALTHY MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH.

NL-OMON49734Pfizer Inc.6

进行中（未招募）

不适用

An open label, single center, non-randomised, phase II study of efficacy Olaparib in patients with BRCA mutation posistive previously treated advanced ocarium canceradvanced ovarian cancerMedDRA version: 17.0Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2014-002014-22-HUOrszágos Onkológiai Intézet

尚未招募

2 期

A Study On Kalladaippu(Urolithiasis) With Aanai Nerunjil Kudineer

CTRI/2022/02/040201Dr SELVAMANI S

招募中

1 期

A PHASE II STUDY OF ADJUVANT ATEZOLIZUMAB OR ATEZOLIZUMAB PLUS TIRAGOLUMAB IN SOLID TUMORS WITH RESECTABLE DISEASE WITH INTERMEDIATE-HIGH RISK OF RECURRENCE AND HIGH TUMOR MUTATIONAL BURDEN OR MICROSATELLITE INSTABILITY (IMperator)

CTIS2024-512635-71-00Roche Farma S.A.40