| CTRI Number |
CTRI/2026/01/100304 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Single Dose Two Period Oral Bioequivalence Study Comparing Cefpodoxime Proxetil Dispersible Tablets 100 mg in Healthy Adult Human Subjects Under Fed 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 ZIPOD 100 DT Cefpodoxime Proxetil Dispersible Tablets 100 mg Manufactured by FDC Limited Village Khol Bhud Tehsil Baddi 173205 Dist Solan H P India with Cepodem DT 100 mg Cefpodoxime Dispersible Tablets Manufactured by Hetero Labs Ltd Unit I Kalyanpur Village Chakkan Road Baddi Tehsil Solan Dist Himachal Pradesh 173 205 and Marketed by Sun Pharmaceuticals Ind Ltd Acme Plaza Andheri Kurla Road Andheri E Mumbai 400 059 in Healthy Adult Human Subjects Under Fed Conditions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0108-25-CEFP Version No: 01 Date: 10 Dec 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 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 No 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 No 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
|
| FDC Limited
142 48 S V Road Jogeshwari W
Mumbai 400102
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
FDC Limited |
| Address |
142 48 S V Road Jogeshwari W
Mumbai 400102
Maharashtra India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Lifescience and Research private limited |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committe ECR/84/lndt/TN/2013/RR-24 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed Condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cepodem DT 100 mg Cefpodoxime Dispersible Tablets |
A Single oral dose of Cepodem DT 100 mg Cefpodoxime Dispersible Tablets will be administered in each period Total Duration of the study is 08 Days |
| Intervention |
ZIPOD 100 DT Cefpodoxime Proxetil Dispersible Tablets 100 mg |
A Single oral dose of ZIPOD 100 DT Cefpodoxime Proxetil Dispersible Tablets 100 mg will be administered in each period Total Duration of the study is 08 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 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 or 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 may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy as documented by 12-lead electrocardiogram ECG Chest X-Ray and clinical laboratory assessments
Willing to consume non vegetarian diet
Willing to comply to all requirements of this study protocol as well as instructed by 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 initiation of the study & a negative urine pregnancy test prior to check-in of each period
If 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
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 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 |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Cefpodoxime Proxetil 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 which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or Xanthine containing products ie coffee tea chocolate and 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 an 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 / excess blood loss within 90 days of check-in
Ingestion of any hormonal agent at any time within 14 days prior to start of 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 likely to become pregnant during conduction 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 ZIPOD 100 DT Cefpodoxime Proxetil Dispersible Tablets 100 mg Manufactured by FDC Limited Village Khol Bhud
Tehsil Baddi 173205 Dist Solan H P India with Cepodem DT 100 mg Cefpodoxime Dispersible Tablets Manufactured by Hetero Labs Ltd Unit I
Kalyanpur Village Chakkan Road Baddi Tehsil Solan Dist Himachal Pradesh 173 205 and Marketed by Sun Pharmaceuticals Ind Ltd Acme Plaza Andheri Kurla Road Andheri E Mumbai 400 059 in Healthy Adult Human Subjects under Fed Conditions |
20 Time points
00 00 Hrs 01 00 Hrs 01 33 Hrs 01 67 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 03 25 Hrs 03 50 Hrs 03 75 Hrs 04 00 Hrs 04 50 Hrs 05 00 Hrs 06 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs 24 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 fed conditions |
20 Time points
00 00 Hrs 01 00 Hrs 01 33 Hrs 01 67 Hrs 02 00 Hrs 02 25 Hrs 02 50 Hrs 02 75 Hrs 03 00 Hrs 03 25 Hrs 03 50 Hrs 03 75 Hrs 04 00 Hrs 04 50 Hrs 05 00 Hrs 06 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs 24 00 Hrs |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
28/04/2026 |
| 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 42 number of healthy adult human subjects will be recruited to evaluatethe 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 42 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 05 days will be maintained between each dosing period In each period, after an overnight fasting of at least 10.00 hours in the morning high-fat, high-calorie, non-veg breakfast will be provided 30 minutes before dosing. After consumption of high-fat, high-calorie, non-veg breakfast in the morning a single oral dose of either the test product T or reference product R will beadministered as per the randomization schedule The dispersible tablet shall be placed in a dosing cup containing 200 mL water, allowed to fully disintegrate with gentle swirling by use of spactuala and administered immediately after dispersion. Subjects rinses the glass with a reamin volume of water (40 mL) to ensure full dose consumption to the subjects sitting in upright posture, under the supervision of the investigator or medical officer and/or trained study personnel, including the quality assurance auditor(s) or monitors |