Phase I Non-Randomized Single sequence Drug Drug interaction study
- Registration Number
- CTRI/2022/12/048142
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Healthy adult human female subjects aged between 18 and 45 years (inclusive).
Subjects with a BMI between 18.50â??30.00 Kg/m2 but with a body weight of not less than 50.00 Kg.
Subjects with normal health as determined by their personal medical history, clinical examination and laboratory examinations, including serological tests.
Results from clinical laboratory tests, including serological tests, which are normal or not clinically significant.
Subjects having a normal or not clinically significant 12-lead electrocardiogram (ECG).
Subjects having a normal or not clinically significant chest X-Ray (P/A view), if taken at screening.
Ability to comprehend and be informed of the nature of the study as assessed by site staff. Capable of giving written informed consent before receiving any study medication. Subjects able to communicate effectively with clinic staff.
Availability to volunteer for the entire study duration and willingness to adhere to all protocol requirements.
must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to initiation of the study.
Negative breath alcohol test result at check-in.
Negative urine drug of abuse test result (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine) at check-in.
Ability to fast and consume standard meals.
Subject should be non-smokers and non-alcoholics
Subjects that can provide adequate evidence of their identity.
Negative pregnancy test as determined by serum β-hCG test at screening and prior to check-in and agrees to use barrier contraceptives from the last dose of study drug to 14 days post study to sufficiently minimize the risk of pregnancy.
Alanine transaminase (ALT), alkaline phosphatase and bilirubin <=1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
The subjects will be excluded from the study if they meet any of the following criteria:
Hypersensitivity to Oral contraceptives or to any of the formulation excipients
Subjects with history of hypertension, stroke, ischemic heart disease, venous thromboembolism or family history of thromboembolism, known factor V Leiden mutation or other gene mutations associated with increased risk of thromboembolism, migraine headaches, carcinoma of the breast, liver or endometrium, gallbladder disease, history of undiagnosed abnormal uterine bleeding
History or presence of significant pulmonary, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
History or presence of Hypotension (less than 90 mm Hg systolic pressure) or cardiogenic shock.
Exclusion criteria for screening ECG (Heart rate: <50 and >100 beats per minute [bpm], PR Interval: <120 and >220 milliseconds [msec], QRS duration: <70 and >120 msec, QTc interval [Bazett]: >450 msec): evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization); any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular (AV) block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome); sinus pauses > 3 seconds; any significant arrhythmia which, in the opinion of the principal investigator and sponsor medical monitor, will interfere with the safety for the individual subject; non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
History or presence of smoking.
History or presence of asthma, urticaria or other allergic reactions.
History or presence of gastric and/or duodenal ulceration.
History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
History or presence of cancer.
Difficulty with donating blood.
Pregnant and lactating females.
Difficulty in swallowing solids like tablets and/or capsules.
Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or use of OTC medicinal products during the week prior to study initiation.
Subject chewed/consume pan or pan masala, gutkha masala (containing betel nut, etc), xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and poppy containing food for 48 hours prior to initiation of the study.
Consumption of grapefruit and/ or their juice within 7 days prior to the first period check-in and until the end of the study.
Major illness during the 90 days before screening.
Participation in a drug research study within 90 days of screening.
Donation of blood within 90 days of screening.
Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
History or presence of easy bruising or bleeding.
Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets etc.
Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception from the last day of study medication to 14 days after study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC(0-ð???)ss, Cmax.ss, and Cð???.ð?? ð?? for Ethinyl Estradiol (EE) and Levonorgestrel (LNG)Timepoint: PK Sampling for EE and LNG â?? <br/ ><br> <br/ ><br>Day 09: 0.00 <br/ ><br> <br/ ><br>Day 10: 0.00, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, and 24.00 hours post dose. <br/ ><br> <br/ ><br>Day 24: 0.00 <br/ ><br> <br/ ><br>Day 25: 0.00, 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 24.00, 48.00 and 72.00 hours <br/ ><br> <br/ ><br>PK Sampling for HRF-10071 <br/ ><br> <br/ ><br>Day 24: 0.00 <br/ ><br> <br/ ><br>Day 25: 0.00, 0.25, 0.50, 1.00, 2.00, 3.00, 4.00, 6.00, 7.00. 8.00, 10.00, 12.00, 14.00, 16.00, 20.00 and 24.00 hours <br/ ><br>
- Secondary Outcome Measures
Name Time Method Serum LH, FSH, and progesterone levels. <br/ ><br>Steady state PK parameters of HRF-10071 - AUC(0-ð???)ss, Cmax.ss, Cð???. ð?? ð?? , Tmax.ss, T1/2 <br/ ><br>Steady state PK parameters of Ethinyl Estradiol (EE) and Levonorgestrel (LNG) â?? Tmax.ss, T1/2 <br/ ><br>Safety and tolerability parameters for AEs/SAEs, observed and change from baseline clinical laboratory assessments, ECGs and vital signs measurements.Timepoint: 53 PK blood samples of 05 mL each and 05 PD blood samples of 04 mL each will be collected from each subject in this study period. <br/ ><br>The subjects will leave the facility after 72.00 hours post dose blood sample of Day 25.