None listed
Conditions
Interventions
Intervention1: Prazosin Hydrochloride Sustained Release tablets 5 mg: After overnight fasting for at least 10.00 hours, one extended-release tablet formulation of Prazosin Hydrochloride Sustained Rele
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal healthy human adult male and/or female volunteers aged between 18-45 years (both ages inclusive). 2. Volunteer provided written informed consent and are willing to participate in the study. 3. Volunteer with Body Mass Index of 18.50 to 30.00 Kg/m2 (both inclusive). 4. A total body weight >50 kg (110 lb). 5. No evidence of underlying disease during pre-study screening, medical history, physical examination and laboratory investigations done within 21 days prior to commencement of the study. 6. Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study. 7. Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR. 8. Negative test results for alcohol (in urine), negative urine drugs of abuse test. 9. 12 lead ECG recording either normal or within acceptable limits or considered by the Investigator to be of no clinical significance with respect to his/her participation in the study. 10. Normal or clinically non - significant chest X-ray (PA) taken within 06 months before the day of dosing. 11. Available for the entire study and capable of understanding instructions and communicating with the investigators and clinical study facility staff. 12. Female volunteers who is having negative results in urine pregnancy test during screening and Beta hCG-test at the time of check-in. 13. Females with child-bearing potential must agree to use an acceptable method of contraception at least 2 days prior to dosing, during the study & for 07 days following their last dose of IP. 14. Male volunteers and/or female volunteerâ??s partner must agree to use condoms, vasectomy or spermicide in addition to female contraception for additional protection against conception throughout the study & for 07 days following their last dose of IP.
Exclusion criteria
Exclusion criteria: 1. Known allergy to PRAZOSIN HYDROCHLORIDE or any component of the formulation and to any other related drug. 2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 3. Female volunteers who are nursing motherslactating women or are found positive in beta hCG test. 4. History/presence of significant alcohol dependence (abuse) or drug abuse within past 1 year, current alcohol abuse (greater 5 units/week, 1 unit equal to 10 mL or 8 g of pure alcohol) or suspected abuse. 5. Who is every day smoker (who has smoked at least 100 cigarettes in his or her lifetime, and who now smokes every day) or consumption of tobacco products. 6. History/presence of asthma. 7. History/presence of urticaria or other allergic type reactions after taking any medication. 8. History/presence of clinically significant illness within 04 weeks before the start of the study. 9. History/presence of significant Hypersensitivity to heparin. 10. History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs. 11. Scheduled for surgery any time during study or within 07 days after study completion. 12. History of difficulty in donating blood. 13. With unsuitable veins for repeated venipuncture. 14. Participation in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days. 15. Consumption of prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing in Period 1, including topical medication. 16. Hospitalization within 28 days prior to administration of the study medication. 17. History of difficulty in swallowing. 18. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial. 19. With Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 20. With Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and AUC0-â?? of prazosinTimepoint: Assessed after dosing at 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00 and 16.00 hours and during each ambulatory visit in each study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, t½ and Kel of prazosin. Adverse events (AEs).Timepoint: Assessed after dosing at 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00 and 16.00 hours and during each ambulatory visit in each study period. | — |
Countries
India
Contacts
Public ContactDr Charles V Adhav
Pfizer Limited
Outcome results
None listed