None listed
Conditions
Interventions
Intervention1: Propranolol: Arm 1 60 mg 9 AM (+ 30 min)
Control Intervention1: Propranolol: Arm 2 30 mg 9 AM (+ 30 min) and 3 PM (+ 30 min)
Control Intervention2: Propranolol: Arm 3 60 mg 6 PM (+ 30 m
Sponsors
Global Health Private Limited
Vicus Therapeutics Inc
Eligibility
Inclusion criteria
Inclusion criteria: • Signed, written Informed Consent • Body Mass Index (BMI) 18.5-24.9 Kg/m2 (both inclusive) • Men or Women aged 18 to 65 years (both inclusive) • Healthy as determined by medical history, clinical and laboratory examination performed within 7 days before admission day (Day -2) • In the opinion of the principal investigator / co-investigator, be able to comply with the study procedures and restrictions • Adequate blood pressure ( >110/60 mmHg) and heart rate (greater than 70 bpm) • Adequate organ function as determined by the following laboratory values: • ANC >=1,500 /mcL • Platelets >=100,000 / mcL • Hgb >=10 g/dL • Creatinine Clearance >=60 mL/min for subject with creatinine levels > 1.5 X institutional ULN • Total Bilirubin 1.5 ULN • AST (SGOT) and ALT (SGPT)
Exclusion criteria
Exclusion criteria: • Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the dose of treatment. • Is already receiving propranolol or another beta-blocker • Participants with history of sleep disturbance and have history of snoring • Participants who is not able to understand or to comply with the study instructions and requirements or has a history of non-compliance to the medical regimen. • Social Habits: • Use of any tobacco products within 1 year of the start of the study and have difficulty in abstaining from its consumption • Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication • Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication • Any recent, significant change in dietary or exercise habits • A positive test for any drug included in the urine drug screen • History of drug dependence and/or alcohol abuse • Medications: • Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the administration of study medication • Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing • Diseases: • Participants with evidence of bradycardia (70 beats/min), resting hypotension (blood pressure 110/60 mmHg) or A-V block • Participants with any evidence of severe or uncontrolled systemic disease (e.g. severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease], uncontrolled chronic renal disease [glomerulonephritis, nephritic syndrome, Fanconi Syndrome or Renal tubular acidosis]), or current unstable or uncompensated respiratory or cardiac conditions • Has a history or current evidence of any condition (medical or surgical), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subjectâ??s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator • History or presence of serious gastrointestinal, liver, kidney, heart, lung, neurological or blood disease, diabetes or glaucoma in the opinion of Principal Investigator/Co-investigator • History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension etc. • History or presence of any psychiatric illness • A positive HIV, hepatitis B, or hepatitis C test • History of asthma or other pulmonary problems • Abnormal and clinically significant laboratory test results: • Abnormal and clinically relevant ECG tracing • Any clinically significant abnormality in Chest X-Ray • Pregnant and lactating females • Female subjects who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (double-barrier methods - any double combination of: IUD, male or female condom, spermicidal gel, diaphragm, sponge, cervical cap) during the study • Male subjects who are not willing to use reliable contraceptive methods during the study • Allergy or hypersensitivity to propranolol hydrochlori
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the level of melatonin (urinary 6-sulpha¬toxymelatonin (aMT6s)) in healthy volunteers who are receiving different dosing regimens of the beta blocker propranololTimepoint: 24 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure heart rate, blood pressure in patients receiving propranololTimepoint: 24 hrs | — |
Countries
India
Contacts
Public ContactMd Muneeb Ahsan
Medanta The Medicity
Outcome results
None listed