| CTRI Number |
CTRI/2025/09/094030 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to determine food effect of ND 10 (7- Methylxanthine, a caffeine derivative) Extended-
Release Tablets 250 mg two tablets together in healthy human participants |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, two-period, two-sequence,
crossover food effect study of ND 10 (7-Methylxanthine, a caffeine derivative)
Extended-Release Tablets 250 mg two tablets together (total dose 500 mg) of Theialife
Inc. when administered under fasting and fed conditions in normal, healthy, adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25-170 Version 01 Date 14 Aug 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mallu Maheswara Reddy |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd. No: B-17, TIE, Phase-II, Balanagar, Hyderabad 500 037, Telangana, India
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
04067364700 |
| Email |
maheswara.mallu@jeevanscientific.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mallu Maheswara Reddy |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd. No: B-17, TIE, Phase-II, Balanagar, Hyderabad 500 037, Telangana, India
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
04067364700 |
| Email |
maheswara.mallu@jeevanscientific.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mallu Maheswara Reddy |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd. No: B-17, TIE, Phase-II, Balanagar, Hyderabad 500 037, Telangana, India
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
04067364700 |
| Email |
maheswara.mallu@jeevanscientific.com |
|
|
Source of Monetary or Material Support
|
| Theialife Inc.
8 The Green STE 14267, Dover, DE
19901, United States of America. |
|
|
Primary Sponsor
|
| Name |
Dr AKBAR WAJID |
| Address |
Theialife Inc. 8 The Green STE 14267, Dover, DE 19901, United States of America. |
| 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 Mallu Maheswara Reddy |
Jeevan Scientific Technology Ltd |
Clinical Pharmacology Department Fourth floor B17 TIE Phase II Balanagar 500037 India
Hyderabad
TELANGANA |
04067364700
maheswara.mallu@jeevanscientific.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maarg Independent ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting and Fed |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ND 10 (7-Methylxanthine, a caffeine derivative)
Extended-Release Tablets 250 mg two tablets together (total dose 500 mg) |
a single dose of 500 mg(2×250 mg) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Healthy, adult human male participants 18 to 55 years of age both inclusive and weight 50 Kg BMI 18.5 to 30.0 kg per m² including both. Acceptable findings during registration and screening including medical history physical examination laboratory evaluations 12 lead ECG and chest
X Ray postero anterior view.Values of laboratory parameters within normal range or clinically non significant as determined by the investigator or physician. Participants able to communicate effectively. Participants willing to give written informed consent and adhere to all the
requirements of this protocol. Participant willing to abstain from all kinds of alcoholic beverages
smoking or tobacco products caffeine or xanthine containing foods or juices or grapefruit or grapefruit juice from 72.00 hours prior to admission until the last post dose blood sample collection in each period. |
|
| ExclusionCriteria |
| Details |
Participants having history of contraindication or hypersensitivity e.g. anaphylaxis to ND 10 7 Methylxanthine or related group of drugs such as
caffeine theobromine. A history of seizures diabetes migraine hypertension cardiovascular
pulmonary neurological or psychiatric disease or 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. Any known enzyme inducing or inhibiting drug taken within 14 days before the study. Any known drugs that inhibit the adenosine within 14 days before the study. Participation in a drug research study within 90 days prior to dosing of this
study. Blood loss or whole blood donation within 90 days prior to drug administration. Consumption of chocolate caffeine or related products with
caffeine content at least 72.00 hours prior to admission of each period. History of addiction to any recreational drug or drug dependence. An unusual or abnormal diet for whatever reason within 48.00 hours prior to admission of each period e.g. fasting due to religious reasons. History of dehydration from diarrhea vomiting or any other reason within a period of 72.00 hours prior to study admission of each period. Positive results for drugs of abuse benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates in urine during the study admission of each period. Positive results for alcohol consumption tests during the study admission of each period. History of pre existing bleeding disorder. Difficulty with drawing blood. Difficulty in swallowing Investigational products. 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 or minute or more than 100 beats or minute. Use of any prescribed medication or OTC medicinal products including vitamins and herbal medicinal products during last two weeks preceding the first dosing. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of food on bioavailability of ND 10 (7- Methylxanthine) Extended-Release Tablets 250 mg two tablets together (total dose 500 mg) of Theialife Inc. when administered under fasting and fed conditions in normal, healthy, adults. |
Assessment of food effect for Treatment A and Treatment B will be calculated and reported for ln-transformed pharmacokinetic parameters
Cmax, AUC0-t and AUC0-inf for ND 10 (7-Methylxanthine) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of ND 10 (7-Methylxanthine) Extended-Release Tablets 250 mg two tablets together (total dose 500 mg) in normal, healthy, adults, under fasting and fed conditions. |
The safety of the subjects will be monitored during the study The adverse events will be reported accordingly |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
12/09/2025 |
| 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 Applicable |
| 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
|
Participants 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. Participants must be enrolled in the study only after providing written informed consent. Selection of Participants for the study will be done based on assessment against the inclusion and exclusion criteria. |