| CTRI Number |
CTRI/2025/04/084974 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| 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 bioavailability and safety of ND 10 (7 Methylxanthine a caffeine derivative)Extended Release Tablets 500 mg |
|
Scientific Title of Study
|
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose,crossover, comparative bioavailability study of ND 10 (7-Methylxanthine, a caffeine derivative)Extended-Release Tablets 500 mg of Theialife Holdings Limited comparing with ND 10 (7-Methylxanthine, a caffeine derivative) Immediate Release Tablets 400 mg of Theialife HoldingsLimited in healthy, adult, human subjects under fasting condition. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25-036 Version 01 Date 14 Mar 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 B 17 TIE Phase II Balanagar Hyderabad Telangana India
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
|
| 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 B 17 TIE Phase II Balanagar Hyderabad Telangana India
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
|
| 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 B 17 TIE Phase II Balanagar Hyderabad Telangana India
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
|
| Email |
maheswara.mallu@jeevanscientific.com |
|
|
Source of Monetary or Material Support
|
| Theialife Holdings Limited c/o AMS Group, Sea Meadow House, P O Box 116, Road Town, Tortola,British Virgin Islands |
|
|
Primary Sponsor
|
| Name |
Dr AKBAR WAJID |
| Address |
Theialife Holdings Limited c/o AMS Group, Sea Meadow House, P O Box 116, RoadTown, Tortola, British Virgin Islands |
| 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 PharmacologyDepartment, Fourth floor,B 17 TIE Phase II Balanagar Hyderabad 500037 Telangana 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 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ND 10 (7-Methylxanthine, a caffeine derivative)Extended-Release Tablets 500 mg |
Twice a day, 12 hours apart,Total of 1000 mg/day, The total expected duration of the study will be at least 10 days
(including the 36.00 hours prior to morning dose in period 01 till the
last-post dose blood sample collection in period 02). The washout
period will be at least 05 days. |
| Comparator Agent |
ND 10 (7-Methylxanthine, a caffeine derivative)Immediate Release Tablets 400 mg |
Thrice a day, 8 hours apart,Total of 1200 mg/day
The total expected duration of the study will be at least 10 days
(including the 36.00 hours prior to morning dose in period 01 till the
last-post dose blood sample collection in period 02). The washout
period will be at least 05 days. |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
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) andweight greater than 50 Kg (BMI 18.5 to 30.0 kg/m²) (including both)
Acceptable findings during registration and screening including, medical history, physicalexamination, laboratory evaluations, 12- lead ECG and Chest X-Ray (postero-anteriorview)
Values within normal ranges of laboratory parameters upon evaluation by theInvestigator or Physician for any of the following tests.
Subjects able to communicate effectively with study personnel
Subjects willing to give written informed consent and adhere to all the requirements ofthis protocol
Non-smokers and non-alcoholic
Subject willing to abstain from all kinds of caffeine/xanthine containing foods or juices orgrapefruit or grapefruit juice from 72.00 hours before period 01 admission till the lastpost dose blood sample collection of the study
Female subjects
Postmenopausal for at least 1 year or
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy hasbeen performed on the subject) or
Female of childbearing potential practicing an acceptable method of birth control for theduration of the study at least two weeks thereafter as judged by the investigator(s),such as condoms, foams, jellies, diaphragm, and intrauterine device (IUD) or abstinence |
|
| ExclusionCriteria |
| Details |
Subjects having a history of contraindication or hypersensitivity (e.g., anaphylaxis) to ND10 or related group of drugs.
A history of significant asthma, urticaria, or other allergic-type reactions after takingaspirin 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 infectiousdiseases, or any other significant abnormality as evidenced by medical history andphysical examination or according to the opinion of the physician.
History of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of thestomach, small intestine, or large intestine.
History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), andtoxic 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/day).
History of addiction to any recreational drug or drug dependence.
An unusual or abnormal diet, for any reason within 48.00 hours prior to admission ofeach period, e.g. fasting due to religious reasons.
History of dehydration from diarrhea, vomiting or any other reason within a period of72.00 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 (breath analysis/ urine alcohol) consumption test during thestudy admission of each study period.
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/minute or more than 100 beats/minute.
Use of any prescription drugs within 07 days or at least 5 half lives of the compoundwhichever period is longer prior to study admission. And use of any herbal medicines andany OTC medications including vitamins within 14 days or at least 5 half lives of thecompound whichever period is longer prior to study admission.
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 anytimeduring the 6 months prior to study or used hormonal contraceptives within 14 daysbefore dosing. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the bioavailability of ND10 Extended-Release Tablets 500 mgof Theialife Holdings Limited with ND10 Immediate Release Tablets 400mg of Theialife Holdings Limited inhealthy, adult, human subjects underfasting condition. |
Treatment A will be considered as bioequivalent to the Treatment B under fasting condition if 90% confidence intervals for the difference of geometric least square means of ln-transformed Pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf of ND 10 (7-Methylxanthine, a caffeine derivative) falls within 80.00-125.00%. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety andtolerability of ND 10 Extended-Release Tablets 500 mg & ND10 Immediate Release Tablets400 mg in normal, healthy,adult, human subjects underfasting condition. |
The safety of the subjects will be monitored during the study The adverse events will be reported accordingly |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
27/04/2025 |
| 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
|
Subjects will undergo a screening procedure comprising clinical examination, recording ofelectrocardiogram and laboratory investigation of blood as well as urine which will be valid for 21days from the day of screening. Radiological investigations (chest X-ray) will be repeated, if notdone in the past 6 months or if clinically indicated at the time of screening. Subjects must beenrolled in the study only after providing written informed consent. Selection of subjects for thestudy will be done based on assessment against the inclusion and exclusion criteria. |