An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Four Period Fully Replicate Reference Scaled Average Oral Bioavailability Study Comparing Esomeprazole Delayed Release 20 mg Mini Capsule Manufactured by Marksans Pharma For Nova Pharm With Nexium Esomeprazole Magnesium Trihydrate 20 mg Tablets Distributed by Astrazeneca Pty Ltd In Healthy Adult Human Subjects Under Fasting Conditions
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- To assess the Bioavailability on Esomeprazole Delayed Release 20 mg Mini
Overview
Brief Summary
At least 48 number of healthy adult human subjects will be recruited to evaluate the Bioavailability of Test product with the Reference product
As per the discretion of the Investigator a sufficient number of stand-by subjects will be included additionally to ensure successful dosing of 48 subjects in period I alone
Note If needed the study will be conducted as batch wise
In each period subjects will be housed in the clinical facility for at least 11.00 hours
pre-dose to 24.00 hours post-dose A washout period of at least 06 days will be maintained between each dosing period
In each period after an overnight fasting of at least 08.00 hours In the morning a single oral dose of either the test product T or reference product R will be administered as per the randomization schedule with 240 mL of drinking water at
ambient temperature
Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre-dose 00.00 hour within 75 minutes of before dosing and at 03.00 06.00 and 12.00 hours (±60 minutes) post-dose
Physical examination and vitals will be recorded before check-in check-out 24.00 hours for each period and at any time if necessary
Monitoring for adverse events will be done throughout the study period in clinical phase
Study Design
- Study Type
- Ba/be
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Normal healthy adult human male and female subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg per m2 to 30.00 kg per m2 Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits are considered by the physician or principal or clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto-vegetarian diet Willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers Generally healthy, as documented by gynaecological examination and breast examination period I only Females of childbearing potential must have a negative serum pregnancy test performed within 21days prior to the initiation of the study and a negative urine pregnancy test prior to check in for each period If the subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of non-childbearing potential defined as greater or equal to 01 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy or is of childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide intrauterine device IUD with a low failure rate of less than 1 percentage per year or is of childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active.
Exclusion Criteria
- •Evidence of allergy or known hypersensitivity to Esomeprazole or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing products i.e. coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48:00 hours prior to check-in and throughout the entire study Consumption of alcohol and its products grapefruit and or its juice, and poppy containing foods within 48:00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study Subjects who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check in History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse Marijuana THC amphetamine-AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check-in of each period Positive results for alcohol test prior to check-in of each period Any blood donation or excess blood loss within 90 days of check in Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in Use of hormone replacement therapy for a period of 06 months prior to dosing Female subjects demonstrating a positive pregnancy screen Female subjects who are currently lactating Females are likely to become pregnant during the course of the study.
Outcomes
Primary Outcomes
To assess the Bioavailability on Esomeprazole Delayed Release 20 mg Mini
Time Frame: 21 Time points | 00 00 Hrs 00 17 Hrs 00 33 Hrs 00 50 Hrs 00 67 Hrs 00 84 Hrs 01 00 Hrs 01 25 Hrs 01 50 Hrs 01 75 Hrs 02 00 Hrs 02 33 Hrs 02 67 Hrs 03 00 Hrs 03 50 Hrs 04 00 Hrs 05 00 Hrs 06 00 Hrs 08 00 Hrs 12 00 Hrs 24 00 Hrs
Capsule Manufactured by Marksans Pharma For Nova Pharm With Nexium
Time Frame: 21 Time points | 00 00 Hrs 00 17 Hrs 00 33 Hrs 00 50 Hrs 00 67 Hrs 00 84 Hrs 01 00 Hrs 01 25 Hrs 01 50 Hrs 01 75 Hrs 02 00 Hrs 02 33 Hrs 02 67 Hrs 03 00 Hrs 03 50 Hrs 04 00 Hrs 05 00 Hrs 06 00 Hrs 08 00 Hrs 12 00 Hrs 24 00 Hrs
Esomeprazole Magnesium Trihydrate 20 mg Tablets Distributed by Astrazeneca
Time Frame: 21 Time points | 00 00 Hrs 00 17 Hrs 00 33 Hrs 00 50 Hrs 00 67 Hrs 00 84 Hrs 01 00 Hrs 01 25 Hrs 01 50 Hrs 01 75 Hrs 02 00 Hrs 02 33 Hrs 02 67 Hrs 03 00 Hrs 03 50 Hrs 04 00 Hrs 05 00 Hrs 06 00 Hrs 08 00 Hrs 12 00 Hrs 24 00 Hrs
Pty Ltd In Healthy Adult Human Subjects Under Fasting Conditions
Time Frame: 21 Time points | 00 00 Hrs 00 17 Hrs 00 33 Hrs 00 50 Hrs 00 67 Hrs 00 84 Hrs 01 00 Hrs 01 25 Hrs 01 50 Hrs 01 75 Hrs 02 00 Hrs 02 33 Hrs 02 67 Hrs 03 00 Hrs 03 50 Hrs 04 00 Hrs 05 00 Hrs 06 00 Hrs 08 00 Hrs 12 00 Hrs 24 00 Hrs
Secondary Outcomes
- To monitor the safety and tolerability of test product comparing with the reference(product in healthy adult human subjects under fasting conditions)
Investigators
Dr Pradeep T
Spinos Lifescience and research private limited