| CTRI Number |
CTRI/2026/01/101422 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
Nil |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study Comparing Duloxetine 120 mg Capsules with Cymbalta® in Healthy Volunteers under Fasting & Fed Conditions. |
|
Scientific Title of Study
|
An Open Label, Balanced, Randomized, Two-Treatment, Two-Sequence, Four-Period,
Full-Replicate, Cross-over, Single Dose Oral Bioequivalence Study of Test Product (T): Duloxetine Delayed-Release Capsules 120 mg Manufactured by Towa Pharmaceutical Europe, S.L., Barcelona, Spain Compared with Reference Product (R): Cymbalta® (Duloxetine) Hard Gastro-Resistant Capsules 60 mg (2 x 60 mg capsules) Marketin Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands in Healthy Adult Male and Female Human Subjects under Fasting & Fed Condition. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CS25113 Version no:00 date: 18 Jun 2025 |
Protocol Number |
| CS25114 Version no:00 date: 18 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeeva Reddy K |
| Designation |
Principal Investigator |
| Affiliation |
Admerus Biosciences Private Limited |
| Address |
Survey No. 480, Basuragadi Village,
Gowdavalli Grampanchayath,
Medchal Mandal and District
Hyderabad-501 401
Telangana, India
Medchal
TELANGANA
501401
India |
| Phone |
914067927777 |
| Fax |
914067927777 |
| Email |
sanjeevareddy.k@admerus.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeeva Reddy K |
| Designation |
Principal Investigator |
| Affiliation |
Admerus Biosciences Private Limited |
| Address |
Survey No. 480, Basuragadi Village,
Gowdavalli Grampanchayath,
Medchal Mandal and District
Hyderabad-501 401
Telangana, India
TELANGANA
501401
India |
| Phone |
914067927777 |
| Fax |
914067927777 |
| Email |
sanjeevareddy.k@admerus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeeva Reddy K |
| Designation |
Principal Investigator |
| Affiliation |
Admerus Biosciences Private Limited |
| Address |
Survey No. 480, Basuragadi Village,
Gowdavalli Grampanchayath,
Medchal Mandal and District
Hyderabad-501 401
Telangana, India
TELANGANA
501401
India |
| Phone |
914067927777 |
| Fax |
914067927777 |
| Email |
sanjeevareddy.k@admerus.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Towa Pharmaceutical Europe, S.L. |
| Address |
C. St. Marti, 75 97
08107 Martorelles
Barcelona, Spain
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjeeva Reddy K |
Admerus Biosciences Private Limited |
Survey No. 480, Basuragadi Village,
Gowdavalli Grampanchayath,
Medchal Mandal and District
Hyderabad-501 401
Telangana, India
Medchal
TELANGANA |
914067927777
914067927777
sanjeevareddy.k@admerus.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vasavi Medical and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting & Fed |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cymbalta®
(Duloxetine) Hard Gastro-Resistant Capsules 60 mg (2 x 60 mg capsules) |
Cymbalta®
(Duloxetine) Hard Gastro-Resistant Capsules 60 mg (2 x 60 mg capsules) Marketing
Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht,
The Netherlands. |
| Intervention |
Duloxetine Delayed-Release Capsules 120 mg |
Manufactured by Towa Pharmaceutical
Europe, S.L., Barcelona, Spain Compared with Reference Product (R): Cymbalta
(Duloxetine) Hard Gastro-Resistant Capsules 60 mg (2 x 60 mg capsules) Marketing
Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht,
The Netherlands |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Male and Female human subjects aged between 18 years and 45 years (both
inclusive) at the time of screening.
2. Having a Body Mass Index (BMI) between 18.50 and 30.00 kg/m2 (both inclusive)
at the time of screening.
3. Non-smokers and non-alcoholics
4. Subjects whose clinical laboratory values are within normal limits or clinically
insignificant as determined by physician or principal investigator to be of no clinical
significance.
5. Normal values/Report in the Suicidal Risk Assessment in the Context of Psychiatric
Evaluation during period-I check-in.
6. Have normal ECG, Chest X-Ray and vital signs.
7. Subjects willing to adhere to protocol requirements and provide written informed
consent.
8. Male subject should be agreed to use an acceptable contraceptive methods
(condoms,gels etc.) from period-I dosing to15 days after the last dose of the study
medication as a birth control restriction.
9. Females who are
a) Childbearing potential willing to practice an acceptable method of birth control
for the duration of the study and for at least 14 days after completion of the
study, such as condoms, foams, jellies, diaphragm, intrauterine devices (IUD)
or abstinence.
b) Surgically sterile (has undergone bilateral tubal ligation, bilateral;
oophorectomy or hysterectomy).
10. Non-Pregnant and non lactating females. |
|
| ExclusionCriteria |
| Details |
1. History or evidence of hypersensitivity Duloxetine or any related products or drugs
or any of its formulation ingredients.
2. History of gastro-oesophageal reflux disease, peptic ulcer disease or any other related
diseases and or any related drugs.
3. Any evidence of impairment of hematopoietic, cardiovascular, renal, hepatic,
endocrine, pulmonary, central nervous, immunological, dermatological,
gastrointestinal, genital, psychiatric disease or disorder.
4. Participation in any clinical research study or any bioavailability bioequivalence
study or blood donation within 90 days prior to first dosing of the present study.
5. History of difficulty in donating blood or difficulty in accessibility of veins.
6. Any food allergy, intolerance, restriction or special diet that, in the opinion of the
Investigator physician could contraindicate the volunteer participation in the study.
7. History of any difficulty in swallowing of solid oral dosage forms such as capsules.
8. Consumption of caffeine and or xanthine containing food or beverages (like tea,
coffee, chocolates or cola drinks or any other) or tobacco containing products (pan
masala, gutka, supari, betel nut etc.,) or alcoholic beverage for at least 48 hours prior
to study check-in of period-I
9. Consumption of broccoli, Brussels sprouts, St. John’s Wort. char-grilled meat,
pomegranate, Seville oranges, star fruit, grapefruit, grapefruit-like or its products
containing these foods for at least 07 days prior to check-in of period-I.
10. Received any prescription drugs or over the counter drugs (OTC) (e.g.: Cold
preparations, antacid preparations, vitamins and natural products used for therapeutic
benefits), or any prescribed medication within 14 days prior to check-in of period-I..
11. Use of any enzyme-modifying drugs prior to 30 days of period-I dosing.
12. Volunteers with positive serology tests.
13. Females with:
a) History of amenorrhea or irregular menstrual periods during last 6 months
b) Pregnancy or planning to become pregnant or breast feeding during the study
c) Usage of hormonal contraceptives either oral or implants
d) Positive test results for pregnancy test during screening or at check-in. |
|
|
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 oral bioequivalence between the Test product (T): Duloxetine Delayed-
Release Capsules 120 mg Manufactured by Towa Pharmaceutical Europe, S.L.,
Barcelona, Spain compared with Reference Product (R): Cymbalta® (Duloxetine) Hard
Gastro-Resistant Capsules 60 mg (2 x 60 mg capsules) Marketing Authorisation Holder:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands in
healthy adult male and female human subjects under fasting condition. |
To assess the oral bioequivalence between the Test product (T): Duloxetine Delayed-
Release Capsules 120 mg Manufactured by Towa Pharmaceutical Europe, S.L.,
Barcelona, Spain compared with Reference Product (R): Cymbalta® (Duloxetine) Hard
Gastro-Resistant Capsules 60 mg (2 x 60 mg capsules) Marketing Authorisation Holder:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands in
healthy adult male and female human subjects under fasting condition. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor the subject’s safety & tolerability of single oral dose of
investigational products (IPs). |
For CS25113 (Fasting): 1.00 to 24.00 hours, & at 36.00, 48.00, & 72.00 hours post-dose.
For CS25114 (Fed): 1.00 to 24.00 hours, & at 36.00, 48.00, & 72.00 hours post-dose. |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="16" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is an open label balanced randomized two treatment two sequence four period full replicate crossover single dose oral bioequivalence study conducted in healthy adult male and female human subjects under fasting & Fed conditions. The primary purpose of the study is to compare the bioavailability of the test product Duloxetine Delayed Release Capsules 120 mg manufactured by Towa Pharmaceutical Europe SL Spain with the reference product Cymbalta Duloxetine hard gastro resistant capsules 60 mg administered as two capsules. The study is designed to evaluate whether the test and reference products are bioequivalent based on pharmacokinetic parameters such as Cmax and AUC. Safety and tolerability of both products will also be assessed throughout the study. |