None listed
Conditions
Interventions
Intervention1: Ethinyl Estradiol and Levonorgestrel: Dose: 0.03mg and 0.15mg,Duration and frequency :Each cycle consists of 21 days on medication and a 7-day interval without medication(three weeks
Sponsors
Hetero Labs Limited
Lambda Therapeutic Research
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ct,ss, Cmax,ss, AUC0-t,ssTimepoint: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax,ss, t1/2Timepoint: 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 | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Lambda Therapeutic Research Ltd
Outcome results
None listed