| CTRI Number |
CTRI/2025/04/085476 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| 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 Period Oral Bioequivalence Study Comparing Nifedipine Tablets 30 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 Nifedipine Controlled Release Tablets 30 mg Manufactured by Guangdong P D Pharmaceutical Co Ltd China With Adalat GITS Nifedipine Controlled Release Tablets 30 mg Manufacturedby Bayer AG Kaiser Wilhelm Allee 51368 Leverkusen Germany In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0001-25-NIFE Version No: 01 Date: 15 Feb 25 |
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 No 29 A Krishna Maduravanam Vellakinar pirivuThudiyalur Coimbatore
Coimbatore TAMIL NADU India
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 No 29 A Krishna Maduravanam Vellakinar pirivuThudiyalur Coimbatore
Coimbatore TAMIL NADU India
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 No 29 A Krishna Maduravanam Vellakinar pirivuThudiyalur Coimbatore
Coimbatore TAMIL NADU India
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Guangdong P D Pharmaceutical Co Ltd Kaiping City 529331 Guangdong Province China |
|
|
Primary Sponsor
|
| Name |
Guangdong P D Pharmaceutical Co Ltd Kaiping City Guangdong Province China |
| Address |
No 66 P D Avenue Yueshan Town Kaiping City 529331 Guangdong Province China |
| 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 Coimbatore641029 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 GroundFloor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore 641029
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 EthicsCommittee RegistrationNoECR/84/Indt/TN/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adalat GITS Nifedipine Controlled ReleaseTablets 30 mg Manufactured by Bayer AGKaiser Wilhelm Allee 51368 Leverkusen Germany |
A Single oral dose of Adalat GITS NifedipineControlled Release Tablets 30 mg will beadministered in each period Total Duration is13 Days |
| Intervention |
Nifedipine Controlled Release Tablets 30 mgManufactured by Guangdong P DPharmaceutical Co Ltd China |
A Single oral dose of Nifedipine ControlledRelease Tablets 30 mg will be administered ineach period Total Duration is 13 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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 29.99 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 physicianor 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 nervoussystem 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 Ionly
Females of child bearing 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 foreach 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 serumpregnancy 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 controlas defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film withspermicide
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 acceptablemethod of birth control as defined above for the duration of the study in the event the subjectbecomes sexually active |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Nifedipine or its inactive ingredients
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuseexisting 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 hepaticcardiovascular Musculoskeletal respiratory central nervous system or any other body systemincluding presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and /or xanthine containing products ie coffee tea chocolate caffeinecontaining sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours priorto check in and throughout the entire study
Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within48.00 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 andthroughout the study and any over the counter medicinal products herbal medications within 07 daysprior 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 todosing 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 barbituratesBAR 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 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 |
|
|
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 of Nifedipine Controlled-Release Tablets 30 mg Manufactured by Guangdong P D Pharmaceutical Co Ltd China with Adalat GITS Nifedipine Controlled Release Tablets 30 mg Manufactured by Bayer AG Kaiser Wilhelm Allee 51368 Leverkusen Germany In Healthy Adult Human Subjects Under Fasting Conditions |
26 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 33 hrs 05 67 hrs 06 00 hrs 06 50 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs 72 00 hrs 96 00 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human subjects under fasting conditions |
26 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 33 hrs 05 67 hrs 06 00 hrs 06 50 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs 72 00 hrs 96 00 hrs |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| Date of Study Completion (India) |
17/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 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 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 07 days will be maintained between each dosing period In each 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 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 02.00 03.00 06.00 12.00 and 24.00 hours ± 60 minutes post dose ECG will be recorded before check out 48.00 hours for each period and if any subject is withdrawn or dropped out during the study Monitoring for adverse events will be done throughout the study period in clinical phase |