| CTRI Number |
CTRI/2024/02/062927 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to determine the absorption and safety of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg |
|
Scientific Title of Study
|
An open label single treatment single period single strength twice daily dosing bioavailability
study of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg of Theialife Sciences in healthy adult human subjects under fed conditions |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 24-001, Version 01 Date 19 Jan 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chodisetti S S Viprusha |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd,
Clinical pharmacology Department,
Forth floor
B 17 TIE Phase II Balanagar
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
|
| Email |
sudha.chodisetti@jeevanscientific.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chodisetti S S Viprusha |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd,
Clinical pharmacology Department,
Forth floor
B 17 TIE Phase II Balanagar
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
|
| Email |
sudha.chodisetti@jeevanscientific.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chodisetti S S Viprusha |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd,
Clinical pharmacology Department,
Forth floor
B 17 TIE Phase II Balanagar
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
|
| Email |
sudha.chodisetti@jeevanscientific.com |
|
|
Source of Monetary or Material Support
|
| Theialife Sciences
(a Bioplus Life Sciences Pvt. Ltd group company)
Pharmed Gardens,
Whitefield Road,
Bangalore -560 048,
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr AKBAR WAJID |
| Address |
Theialife Sciences a Bioplus Life Sciences Pvt Ltd group companyPharmed Gardens
Whitefield Road
Bangalore 560 048
|
| Type of Sponsor |
Other [Self] |
|
|
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 Chodisetti S S Viprusha |
Jeevan Scientific Technology Ltd |
B17 TIE Phase II Balanagar
Hyderabad 500037 Telangana India
Hyderabad
TELANGANA |
04067364700
sudha.chodisetti@jeevanscientific.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bioethics Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fed |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg |
Dose: 1000 mg per day
Frequency: Twice daily (Morning dose 500 mg and Evening dose 500 mg)
Route of administration: Oral
Total duration: 1 day |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult human subjects between 18 to 45 years of age including both and weight greater than 50 Kg BMI 18.5 to 24.9 kg per m²
Acceptable findings during registration and screening including medical history physical examination laboratory evaluations 12 lead ECG and Chest X Ray postero anterior view
Values within normal ranges of laboratory parameters upon evaluation by the Investigator or Physician
Subjects able to communicate effectively with study personnel
Subjects willing to give written informed consent and adhere to all the requirements of this protocol
Subject willing to abstain from all kinds of caffeine xanthine containing foods or grapefruit or grapefruit juice from 72 hours prior to admission until last blood sample collection in study period
Female subjects
Postmenopausal for at least 1 year or
Surgically sterile bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject or
Female of childbearing potential practicing an acceptable method of birth control for the duration of the study at least two weeks thereafter as judged by the investigator such as condoms foams jellies diaphragm and intrauterine device IUD or abstinence
|
|
| ExclusionCriteria |
| Details |
Subjects having a history of contraindication or hypersensitivity example anaphylaxis to ND 10 (7 Methylxanthine a caffeine derivative) or related group of drugs
A history of significant asthma urticarial or other allergic type reactions after taking aspirin or other NSAIDs
A history of seizures diabetes migraine hypertension cardiovascular pulmonary neurological or psychiatric disease disorder dermatological endocrine eye disorders immunological hepatic renal hematopoietic gastrointestinal ongoing infectious diseases or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician
History of gastrointestinal GI inflammation bleeding ulceration and perforation of the stomach small intestine or large intestine
History or evidence of exfoliative dermatitis Stevens Johnson syndrome SJS and toxic epidermal necrolysis TEN
Have significant diseases or clinically significant abnormal findings during screening medical history physical examination clinical examination laboratory evaluations ECG chest X ray recording etc
Any known enzyme inducing or inhibiting drug taken within 14 days before the study
Participation in a drug research study within 90 days prior to admission of this study
Blood loss or whole blood donation within 90 days prior to drug administration
Consumption of high caffeine more than 5 cups of coffee or tea per day
History of addiction to any recreational drug or drug dependence
An unusual or abnormal diet for any reason within 48 hours prior to admission example fasting due to religious reasons
History of dehydration from diarrhea vomiting or any other reason within a period of 72 hours prior to study admission
Positive results for drugs of abuse benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates in urine during the study admission
Positive results for alcohol breath analysis urine alcohol blood alcohol consumption test during the study admission
History of pre existing bleeding disorder
Difficulty in swallowing Investigational products
Difficulty with donating blood
Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg
Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg
Pulse rate less than 60 beats per minute or more than 100 beats per minute
Use of any prescription drugs within 07 days or at least 5 halflives of the compound whichever period is longer prior to study admission and use of any herbal medicines and any OTC medications including vitamins within 14 days or at least 5 halflives of the compound whichever period is longer prior to study admission
Symptoms of COVID19 or positive COVID19 test result within the past 30 days
Female subjects demonstrating a positive pregnancy screen
Female volunteer who is pregnant or currently breast feeding
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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate bioavailability of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg of Theialife Sciences in healthy adult human subjects under fed conditions |
27 time points at 00.00, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 12.50, 13.00, 13.50, 14.00, 14.50, 15.00, 15.50, 16.00, 17.00, 18.00, 20.00, 22.00 and 24.00 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety and tolerability of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg in healthy adult human subjects under fed conditions
To assess the Pharmacokinetic Parameters of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release Tablets 500 mg
To compare rate and extend of drug absorption of ND 10 (7 Methylxanthine a caffeine derivative) Extended Release 500 mg tablet with historical data of ND 10 (7-Methylxanthine immediate release 400 mg tablet |
27 time points at 00.00, 00.50, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 12.50, 13.00, 13.50, 14.00, 14.50, 15.00, 15.50, 16.00, 17.00, 18.00, 20.00, 22.00 and 24.00 hours |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
29/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Study
subjects will undergo a screening procedure comprising clinical examination,
recording of electrocardiogram and laboratory investigation of blood as well as
urine which will be valid for 21 days from the day of screening. Radiological
investigations (chest X-ray) will be repeated, if not done in the past 6 months
or if clinically indicated at the time of screening. Subjects must be enrolled in the study only after
providing written informed consent. Selection of subjects for the study
will be done based on assessment against the inclusion and exclusion criteria. |