An Open Label Balanced Randomized Single Dose Three Treatment Three Sequence Three Period Three Way Crossover Comparative Oral Bioavailability Study Comparing Candesartan Cilexetil Oral Suspension 32 Mg Per Bottle Manufactured By Beijing Sciecure Pharmaceuticals Co Ltd China With Atacand Candesartan Cilexetil 32 Mg Tablets Manufactured By Ani Pharmaceuticals Inc Baudette In Healthy Adult Human Male Subjects Under Fed Condition
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Brillian Pharma Inc
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- To assess the Comparative Oral Bioavailability of Candesartan Cilexetil Oral Suspension 32 mg/Bottle Manufactured by Beijing Sciecure Pharmaceuticals Co Ltd China with ATACAND Candesartan Cilexetil 32 mg Tablets Manufactured by Ani Pharmaceuticals Inc Baudette In Healthy Adult Human Male Subjects Under Fed Conditions
Study Overview
Brief Summary
| At least 18 numbers of healthy adult human male subjects will be recruited to evaluate the Bioavailabilty of Test products 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 18 subjects in period I alone
In each period subjects will be housed in the clinical facility for at least 11.00 hours pre-dose to 48.00 hours post-dose
A washout period of at least 03 days will be maintained between each dosing period
After an overnight fasting of at least 10.00 hours prior to high fat high calorie non veg breakfast
In the morning high fat high calorie non veg breakfast will be provided 30 minutes before dosing
In the morning a single oral dose of either the test product T1 or T2 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 01.00 hrs 02.00 hrs 04.00 hrs 06.00 hrs 08.00 hrs 12.00 hrs 24.00 and 36.00 hours Plus or minus 60 minutes post dose
Physical examination and vitals will be recorded before check-in, check-out 48.00 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
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Normal healthy adult human male subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 29.99 kg/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.
Exclusion Criteria
- •Evidence of allergy or known hypersensitivity to Candesartan Cilexetil 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 ie 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 swallowing 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.
Outcomes
Primary Outcomes
To assess the Comparative Oral Bioavailability of Candesartan Cilexetil Oral Suspension 32 mg/Bottle Manufactured by Beijing Sciecure Pharmaceuticals Co Ltd China with ATACAND Candesartan Cilexetil 32 mg Tablets Manufactured by Ani Pharmaceuticals Inc Baudette In Healthy Adult Human Male Subjects Under Fed Conditions
Time Frame: 22 Time points | 00 00 Hrs 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 33 Hrs 02 67 Hrs 03 00 Hrs 03 33 Hrs 03 67 Hrs 04 00 Hrs 04 33 Hrs 04 67 Hrs 05 00 Hrs 05 50 Hrs 06 00 Hrs 06 50 Hrs 07 00 Hrs 08 00 Hrs 12 00 Hrs 24 00 Hrs 48 00 Hrs
Secondary Outcomes
- To monitor the safety and tolerability of a single dose test and reference products administered in Healthy Adult Human Male Subjects Under Fed Conditions(22 Time points)
Investigators
Dr Pradeep T
Spinos Lifescience and research private limited