Randomized, Open Label, Single-Dose, Two Period, Two Treatment, Two Sequence, Cross-over, Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety of Rabeprazole Sodium Delayed-release Capsule 20 mg in Healthy Volunteers.
- Registration Number
- CTRI/2017/07/008985
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Age: 18 to 45 years old, both inclusive.
2. Sex: Male subjects
3. BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5)
4. Able to communicate effectively with study personnel
5. Able to give written informed consent to participate in the study.
6. Subjects with negative results for H. pylori IgG antibody at screening
7. Subjects judge by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication.
1. History of allergic responses to rabeprazole or similar drugs or other constituents of the formulation.
2. Have significant diseases or clinically significant abnormal finding during screening medical history, physical examination, laboratory evaluations, ECG and chest X-ray recording.
3. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
4. History or presence of bronchial asthma.
5. A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
6. Use of enzyme-modifying drugs within 30 days prior to the first dose of study medication.
7. History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
8. Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
9. History of difficulty with donating blood or difficulty in accessibility of veins.
10. A positive hepatitis screen (includes subtypes B & C).
11. A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
12. Volunteer who have received a known Investigational drug within ten elimination half life of the administered drug prior to the first dose of study medication or have donated blood or loss of blood 50 mL to 100 mL within 30 days or 101 mL to 200 mL within 60 days or >200 mL within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
13. History of difficulty in swallowing or of any gastrointestinal disease which could affect drug absorption.
14. Intolerance to venipuncture.
15. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the volunteerâ??s participation in this study.
16. Any other condition that, in the investigatorâ??s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics Parameters: <br/ ><br>Pharmacokinetic parameters Cmax, AUCt, AUCi, Tmax, Kel and tHalf will be calculated using WinNonlin® professional software (Phoenix Version 6.4 or higher; Pharsight Corporation, USA) <br/ ><br>Pharmacodynamics Parameters:Pharmacodynamic analysis will be calculated using WinNonlin® professional software and/or SAS® statistical software (Version: 9.4 or higher; SAS Institute Inc., USA)Timepoint: Period 1 & 2: <br/ ><br>Pre-dose (0.0 hour) and at 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 6.33, 6.66, 7.00, 7.50, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hours after start of infusion <br/ ><br>
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil