CTRI/2025/01/079338 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On:
20/01/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A Study to evaluate the blood levels of Carbidopa 61.25 mg and Levodopa 245 mg Capsules as a test compared to the Reference RYTARY (Carbidopa and Levodopa) Capsules 61.25 mg/ 245 mg (R) in normal healthy subjects under fed and fasting condition.
Scientific Title of Study
An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose, oral bioequivalence study of Carbidopa 61.25 mg and Levodopa 245 mg Extended Release Capsules (T) Manufactured by ScieGen Pharmaceuticals, Inc 89 Arkay Drive, Hauppauge, New York- 11788, United States with RYTARY® (Carbidopa and Levodopa) Extended Release Capsules 61.25 mg/ 245 mg (R) Manufactured by Bora Pharmaceutical Laboratories Inc. Jhunan, Taiwan and Distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 in normal healthy, adult male and female subjects under fed and fasting condition.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
S-24-859 and S-24-860, Version 01, dated 10-Oct-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Divya A MD
Designation
MD Principal Investigator
Affiliation
M/s Notrox Research Pvt Ltd (NRPL)
Address
No 19/3, 3rd Floor, Bikasipura Main Rd, JC Industrial Layout Bangalore KARNATAKA 560062 India
Phone
7760829333
Fax
-
Email
drdivya-a@notroxresearch.com
Details of Contact Person Scientific Query
Name
Dr Divya A MD
Designation
MD Principal Investigator
Affiliation
M/s Notrox Research Pvt Ltd (NRPL)
Address
No 19/3, 3rd Floor, Bikasipura Main Rd, JC Industrial Layout Bangalore KARNATAKA 560062 India
Phone
7760829333
Fax
-
Email
drdivya-a@notroxresearch.com
Details of Contact Person Public Query
Name
Dr Divya A MD
Designation
MD Principal Investigator
Affiliation
M/s Notrox Research Pvt Ltd (NRPL)
Address
No 19/3, 3rd Floor, Bikasipura Main Rd, JC Industrial Layout Bangalore KARNATAKA 560062 India
Phone
7760829333
Fax
-
Email
drdivya-a@notroxresearch.com
Source of Monetary or Material Support
ScieGen Pharmaceuticals, Inc
89 Arkay Drive,
Hauppauge, New York- 11788,
United States.
Primary Sponsor
Name
ScieGen Pharmaceuticals, Inc
Address
89 Arkay Drive,
Hauppauge, New York- 11788,
United States
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Divya A
Notrox Research Pvt Ltd
No 19/3,2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road (Behind Metro Cash and carry), Bangalore -560062, Karnataka, India. Bangalore KARNATAKA
7760829333 - drdivya-a@notroxresearch.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Sri Durgamba Independent ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy Human Volunteers
Intervention / Comparator Agent
Type
Name
Details
Intervention
Carbidopa 61.25 mg and Levodopa 245 mg Extended Release Capsules (T) Manufactured by ScieGen Pharmaceuticals, Inc 89 Arkay Drive, Hauppauge, New York- 11788, United States
After an overnight fasting of at least 10.00 hours and exactly 30 minutes after serving of high fat, high calorie non-vegetarian breakfast, a single dose of Carbidopa 61.25 mg and Levodopa 245 mg Extended Release Capsules (T) Manufactured by ScieGen Pharmaceuticals, Inc 89 Arkay Drive, Hauppauge, New York- 11788, United States along with 240±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Comparator Agent
RYTARY® (Carbidopa and Levodopa) Extended Release Capsules 61.25 mg/ 245 mg (R) Manufactured by Bora Pharmaceutical Laboratories Inc. Jhunan, Taiwan
After an overnight fasting of at least 10.00 hours and exactly 30 minutes after serving of high fat, high calorie non-vegetarian breakfast, a single dose of RYTARY® (Carbidopa and Levodopa) Extended Release Capsules 61.25 mg/ 245 mg (R) Manufactured by Bora Pharmaceutical Laboratories Inc. Jhunan, Taiwan and Distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 along with 240±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
Volunteers who accept for participating in this study must be:
1. Healthy, adult male and female, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
2. Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both inclusive) at the time of screening.
3. Normal or clinically insignificant findings during screening, medical history, clinical examination including vital signs, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
4. Able to comply with the study procedures, in the opinion of the Principal Investigator.
5. Compliance with study specific restrictions and prohibitions.
6. Able to give voluntary written informed consent for participation in the trial.
In case of Female subjects:
1. Female subjects who are of child bearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra uterine device during the study.
2. Female subjects who are tested negative for serum pregnancy test at the time of check-in.
3. Female subjects who are tested negative for urine pregnancy test at the time of screening.
ExclusionCriteria
Details
If any subject is having any of the following conditions, will be excluded from the
participation in this study:
1. Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
2. History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
3. History of significant daytime sleepiness or episodes of falling asleep during activities.
4. Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case subject selection will be at the discretion of the Principal Investigator.
5. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
6. Smokers and Alcoholics.
7. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
8. An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
9. The presence of clinically significant abnormal laboratory values during screening.
10. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
11. A history of difficulty with donating blood or having donated blood in the preceding 90 days for males / 120 days for females prior to the start of the study.
12. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days for males / 120 days for females preceding the start of the study.
13. Difficulty in swallowing tablets/ Capsules.
14. Positive HIV, VDRL/RPR, Hepatitis B and C tests.
15. Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
16. Pregnant and lactating women or those using hormonal contraceptives (oral/implants).
17. History of undiagnosed vaginal bleeding (for females only).
18. Female subjects who demonstrates a positive pregnancy during screening or currently breast-feeding.
19. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Cmax, AUC(0-t) and AUC(0-inf)
Total 23 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected and placed in Ice cold bath at each period.
The post-dose blood samples of 4.0 mL will be collected and placed in Ice cold bath at 00.33, 00.68, 01.00, 01.33, 01.68, 02.00, 02.33, 02.68, 03.00, 03.33, 03.68, 04.00, 04.33, 04.68, 05.00, 05.50, 06.00, 08.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose.
Secondary Outcome
Outcome
TimePoints
Tmax, t½, Kel, Kel Lower, Kel Upper and AUCExtrapolated%
Total 23 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected and placed in Ice cold bath at each period.
The post-dose blood samples of 4.0 mL will be collected and placed in Ice cold bath at 00.33, 00.68, 01.00, 01.33, 01.68, 02.00, 02.33, 02.68, 03.00, 03.33, 03.68, 04.00, 04.33, 04.68, 05.00, 05.50, 06.00, 08.00, 10.00, 12.00, 16.00 and 24.00 hours post-dose.
Target Sample Size
Total Sample Size="120" Sample Size from India="120" 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)
31/01/2025
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="1" Months="0" Days="0"
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
After an overnight fasting of at least 10.00 hours and exactly 30 minutes after serving of high fat, high calorie non-vegetarian breakfast, a single dose of Carbidopa 61.25 mg and Levodopa 245 mg Extended Release Capsules (T) Manufactured by ScieGen Pharmaceuticals, Inc 89 Arkay Drive, Hauppauge, New York- 11788, United States or RYTARY® (Carbidopa and Levodopa) Extended Release Capsules 61.25 mg/ 245 mg (R) Manufactured by Bora Pharmaceutical Laboratories Inc. Jhunan, Taiwan and Distributed by Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 along with 240±2 mL of water, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received “all the treatments (T and R) once†by the end of the study