None listed
Conditions
Interventions
Intervention1: Sildenafil and dapoxetine: In one study period, single oral dose of one tablet of test product Sildenafil 50 mg and Dapoxetine 30 mg Tablets manufactured by Hetero Healthcare Ltd. will
Sponsors
Hetero Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects to be enrolled in the study have to meet all of the following criteria: 1. Subjects willing to give Informed Consent. 2. Normal healthy, adult male subjects within 18-45 years of age (both inclusive). 3. Subject with Body Mass Index (BMI) having range between 18.0 and 25.0 (both inclusive), calculated as weight in Kg and height in m2. 4. Willingness to follow protocol requirements as per the subject information sheet. 5. Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study. 6. Subjects whose screening laboratory values are within normal limits or considered by the Physician / Principal Investigator / Co-Investigator to be of no clinical significance. 7. Physical examination and vital sign examination of the subject conducted on the day of screening and check-in are within acceptable limits. 8. Subjects who agree to abstain from consuming any xanthine / caffeine containing food or beverages (chocolates, tea, coffee or cola drinks), grapefruit juice and products, alcoholic products, cigarettes and tobacco products for at least 48.00 hours prior to dosing and throughout the study period until the last blood sample is being obtained.
Exclusion criteria
Exclusion criteria: Subjects will be excluded for ANY ONE of the following reasons: 1. Any known contra-indication Sildenafil and Dapoxetine or related class of drugs. 2. Significant medical disorder (cardiovascular, gastrointestinal, renal, pulmonary, haematological, endocrine, or metabolic disorder (e.g. diabetes mellitus), malignancy, or immunodeficiency disorder, hepatic and neurological or psychiatric) as determined by history. 3. Significant abnormal finding as determined by clinical examination including ECG and vital signs. 4. Difficulty in withdrawing the blood. 5. Difficulty in swallowing the tablet. 6. History or evidence of drug abuse. 7. History of alcohol consumption and/or smoking or consumption of tobacco products. 8. Depot injections or implants within 6 months. 9. Positive screening test for any one: HIV, hepatitis B, hepatitis C and syphilis. 10. Consumption of xanthine / caffeine containing products, tobacco containing products, grapefruit juice and products and alcohol within 48.00 hours prior to dosing. 11. Requirement of any medication for chronic illness. 12. Consumption of any medication (prescribed or OTC) during 21 days prior to dosing and till the end of the study. 13. Subject has a history of allergic response to foods, which are being used in the study meal. 14. Participation in any clinical study during 90 days prior to administration of study medication. 15. Blood donation during 90 days prior to administration of study medication. 16. Clinically significant illness within 4 weeks before start of study. 17. Criteria for blood pressure and pulse: - Systolic blood pressure below 110 mm of Hg or above 140 mm of Hg. - Diastolic blood pressure below 70 mm of Hg or above 90 mm of Hg. Minor deviation (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician / investigator. - Pulse rate below 70/ minute or above 100/ minute. 18. Subjects with any condition, which in the opinion of the investigators makes the subject unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: To assess the bioequivalence between Test product: Sildenafil 50 mg and Dapoxetine 30 mg Tablets manufactured by Hetero Healthcare Ltd., India and Reference product: Caverta 50 (Sildenafil citrate 50 mg Tablets) manufactured by Sun Pharmaceutical Ind. Ltd.and Duralast 30 (Dapoxetine hydrochloride 30 mg Tablets) manufactured by Sun Pharma Laboratories Ltd. under fasting conditions in normal healthy, adult male subjects in a randomized crossover study.Timepoint: Blood samples (5 mL each) will be taken per period, at pre-dose (within 00.50 hrs prior to dosing) and at 00.17, 00.33, 00.50, 00.67, 00.83, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 04.00, 06.00, 08.00, 10.00, 12.00, 24.00, 48.00, 72.00 and 96.00 hours post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: To monitor the safety and tolerability of a single oral dose of Sildenafil 50 mg and Dapoxetine 30 mg Tablets in normal healthy, adult male subjects.Timepoint: Vital signs examination and well-being will be done at the time of recruitment, prior to dosing and at 01.00, 03.00, 06.00, 12.00, 24.00, 48.00, 72.00 and 96.00 hours after administration of the study drug. | — |
Countries
India
Contacts
Public ContactMr P Narender reddy
Bio Scientific Research Laboratories (I) Pvt. Ltd.
Outcome results
None listed