| CTRI Number |
CTRI/2025/01/079266 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
An Open Label Single Dose Two Treatment Two Period Two Way Crossover Oral Bioequivalence Study Comparing Valsartan/Hydrochlorothiazide Tablets USP 320 mg/25 mg In Healthy Adult Human Subjects Under Fasting Conditions |
|
Scientific Title of Study
|
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Valsartan/Hydrochlorothiazide Tablets USP 320 mg/25 mg Manufactured by Incepta Pharmaceuticals Ltd Incepta Bioscience Division with Diovan HCT Valsartan/Hydrochlorothiazide Tablets USP 320 mg/25 mg Distributed by Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0095-24-VALS Version No 01 Dated 13 Nov 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
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| 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
Coimbatore
TAMIL NADU
641029
India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| 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
Coimbatore
TAMIL NADU
641029
India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
8220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Incepta Pharmaceuticals Ltd
40 Shahid Tajuddin Ahmed
Sarani Tejgaon I A
Dhaka 1208 Bangladesh
|
|
|
Primary Sponsor
|
| Name |
Incepta Pharmaceuticals Ltd |
| Address |
40 Shahid Tajuddin Ahmed
Sarani Tejgaon I A
Dhaka 1208 Bangladesh
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
Clinical Pharmacology Unit Ground Floor 29 A Krishna Maduravanam 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 Door
No 29 A Krishna
Maduravanam
Vellakinar pirivu
Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
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 Registration No ECR/84/Indt/TN/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting Condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diovan HCT Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg |
Single Oral Dose of Diovan HCT Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Will Be administered in each Period Total Duration is 10 Days |
| Intervention |
Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg |
Single Oral Dose of Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg 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 |
Both |
| Details |
Normal healthy adult human subjects of age between 18 45 years and Body Mass Index BMI ranges between 18 50 kg m2 to 29 99 kg m2 according to the formula of BMI weight kg height 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 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 instruction from the study personnel
Non smokers
Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days 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 subject s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of non childbearing potential defined as 1 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 1 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
|
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Valsartan and hydrochlorothiazide 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 meals 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 checkin
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 this study period
Positive results for alcohol test prior to check in of each period
Any blood donation excess blood loss within 90 days of checkin
Ingestion of any hormonal agent at any time within 14 days prior to the start of the study checkin
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 who are are likely to become pregnant during the course of the study
|
|
|
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 Bioequivalence on Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Manufactured by Incepta Pharmaceuticals Ltd Incepta Bioscience Division Dhamrai Dhaka Bangladesh with Diovan HCT Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Distributed by Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 |
21 time points
00 00 hrs 00 50 hrs 01 00 hrs 01 33 hrs 01 67 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 08 00 hrs 10 00hrs 12 00 hrs 24 00 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioequivalence on Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Manufactured by Incepta Pharmaceuticals Ltd Incepta Bioscience Division Dhamrai Dhaka Bangladesh with Diovan HCT Valsartan Hydrochlorothiazide Tablets USP 320 mg 25 mg Distributed by Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 |
21 time points
00 00 hrs 00 50 hrs 01 00 hrs 01 33 hrs 01 67 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 08 00 hrs 10 00hrs 12 00 hrs 24 00 hrs |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
18/02/2025 |
| 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
|
An Open-Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Two-Way Crossover, Oral Bioequivalence Design In Healthy, Adult Human Subjects Under Fasting Conditions
At least 16 number of healthy adult human subjects will be recruited to evaluate the Bioequivalence 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 16 subjects in period I alone
In each period subjects will be housed in the clinical facility for at least 11 00 hrs pre dose to 24 00 hrs post dose
A washout period of at least 07 days will be maintained between each dosing period
After an overnight fasting of at least 10 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 hr within 75 minutes of before dosing and at 01.00 02.00 04.00 06.00 08.00 and 12.00 plus or minus 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 |