| CTRI Number |
CTRI/2024/12/077948 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Randomized Single Dose Three Period Crossover Comparative Oral Bioavailability Study Comparing Candesartan Cilexetil Oral Suspension 32 mg per Bottle in healthy male subjects |
|
Scientific Title of Study
|
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 Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0079-24-CAND Version 01 Dated 01 Oct 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Brillian Pharma Inc NJ 08852 USA |
|
|
Primary Sponsor
|
| Name |
Brillian Pharma Inc |
| Address |
11 Deerpark Drive Unit 120 Monmouth Junction NJ 08852 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Life science and Research private limited |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore 641029
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ATACAND Candesartan Cilexetil 32 mg Tablets |
Single Oral Dose of ATACAND Candesartan Cilexetil 32 mg Tablets Will Be administered in each Period Total Duration is 10 Days |
| Intervention |
Candesartan Cilexetil Oral Suspension 32 mg Per Bottle |
Single Oral Dose of Candesartan Cilexetil Oral Suspension 32 mg Per Bottle Will Be administered in each Period Total Duration is 10 Days
|
| Intervention |
Candesartan Cilexetil Oral Suspension 32 mg Per Bottle |
Single Oral Dose of Candesartan Cilexetil Oral Suspension 32 mg Per Bottle Will Be administered in each Period Total Duration is 10 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
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 Outcome
|
| Outcome |
TimePoints |
| 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
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 |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |
|