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CTRI Number  CTRI/2025/10/095911 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical evaluation Safety and Pharmacokinetics of Paraxanthine and Caffeine in the healthy volunteers 
Scientific Title of Study   A prospective, double-blind, randomized, cross-over, three arm, three treatments, three period, placebo-controlled study to evaluate the pharmacokinetic effects of Paraxanthine (PX) in comparison to that of Caffeine (CF) in otherwise healthy volunteers. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CF/PX/2025 Version Number: 1.0 Date: 29-July-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd  
Address  Radiant Research Services Pvt. Ltd Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru-560058, Karnataka, India.

Bangalore
KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd  
Address  Radiant Research Services Pvt. Ltd Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru-560058, Karnataka, India.


KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Ashok Godavarthi 
Designation  CEO 
Affiliation  Radiant Research Services Pvt. Ltd  
Address  Radiant Research Services Pvt. Ltd Plot No:99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru-560058, Karnataka, India.


KARNATAKA
560058
India 
Phone  09880999297  
Fax    
Email  surya.ashok@gmail.com   
 
Source of Monetary or Material Support  
M/S. INGENIOUS INGREDIENTS 7700 Windrose Ave Suite G300 Plano, TX 75024 U.S.A.  
 
Primary Sponsor  
Name  M/S. INGENIOUS INGREDIENTS  
Address  7700 Windrose Ave Suite G300 Plano, TX 75024 U.S.A.  
Type of Sponsor  Other [Nutraceutical supplement company] 
 
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 S Dinesh  Medstar Speciality Hospital   No.641/17/1/3,Ground floor, Department of Medicine Room number 2 Kodigehalli Main Road, Sahakar Nagar Post, Bengaluru, Karnataka -560092.
Bangalore
KARNATAKA 		 9886125229

bhaktha.dinesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medstar Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caffein  Dose : 200 mg Dosage form :Capsule Route of administration: Oral duration: After overnight fasting for at least 10 hours. 
Intervention  Paraxanthine  Dose : 200 mg Dosage form :Capsule Route of administration: Oral duration: After overnight fasting for at least 10 hours. 
Comparator Agent  Placebo  Dose : 200 mg Dosage form :Capsule Route of administration: Oral duration: After overnight fasting for at least 10 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 Subjects must be healthy human male and female 50 percentage each subjects
2 Age should be between 18 to 45 years of age both inclusive weighing at least 50 kg
3 BMI less than 30 kg per m2
4 Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol
5 Subjects willing to give consent for CYP1A2 genotyping
6 Subjects with no evidence of underlying disease during the pre study screening They must be healthy as determined by medical history and physical examination ECG Chest X ray PA View and laboratory tests performed within 7 days prior to the commencement of the study
7 Subjects whose screening laboratory values are within normal limits or considered by the physician or Principal Investigator to be of no clinical significance
 
 
ExclusionCriteria 
Details  1 Subject has a known allergy or sensitivity to any ingredient in the test product
2 Subject with resting hypotension BP less than 90 per 60 or hypertension BP more than 140 per 90 and pulse rate below 50 per min and more than 100 per min
3 Subject with or a prior history or presence of significant cardiovascular pulmonary hepatic renal hematological gastrointestinal endocrine immunologic dermatologic neurological musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in housing.
4 Subjects with a history of MI Stroke Peripheral Arterial Disease GI Bleeding Hepatic Impairment Asthma Renal Impairment Epilepsy and Intracranial hemorrhage
5 Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study
6 Subjects who are hypersensitive to Heparin
7 Subjects who participated in any other clinical study in the past three months
8 Subject with clinically significant abnormal lab values or abnormal ECG or abnormal Chest X-ray PA View
9 Subject who has difficulty with donating blood
10 Subject with history of difficulty in swallowing
11 Subject who has unsuitable veins for repeated venipuncture  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To determine the bioavailability of Paraxanthine (PX) and Caffeine (CF) in plasma
by LC-MS/HPLC. 		 0 min, 10min, 20min, 40min, 60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr and 24hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effects of the test product on overall mood through caffeine
research visual analogue scale (Caff-VAS) 		 Day 0 and Day 1 of Period 1, 2 & 3 
Changes in blood parameters assessed by blood tests: Hematology,
Biochemistry and Urine analysis 		 Screening, Day 0 and Day 1 of Period 1, 2 & 3 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   21/10/2025 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Caffeine is an odorless white powder or white glistening needles, bitter in taste. Solutions in water are neutral to litmus. (NTP, 1992). Caffeine is a trimethyl xanthine in which the three methyl groups are located at positions 1, 3, and 7. A purine alkaloid that occurs naturally in tea and coffee.  It has a role as a central nervous system stimulant, a phosphoric diester hydrolase inhibitor, an adenosine receptor antagonist, a non-specific serine/threonine protein kinase inhibitor, a ryanodine receptor agonist, a psychotropic drug, a diuretic, a food additive. After ingestion, caffeine is quickly absorbed from the gastrointestinal tract into the circulatory system. The maximum plasma concentration is reached after 30-60 minutes from consumption. maximum plasma concentrations reached between 15 and 120 min have been reported.  

Paraxanthine, the key metabolite of caffeine, has a similar chemical structure and half-life to those of caffeine and is easily measured in serum and urine. About 60% of orally ingested paraxanthine is excreted unmodified. Mechanisms of paraxanthine’s potential ergogenic effects include (A) an increase in plasma free fatty acids, a source of fuel that the body can utilize to produce energy, (B) a reduction of plasma K+ concentrations which may attenuate the onset of skeletal muscle fatigue, and (C) an increase in calcium ions in the skeletal muscle, which is involved in muscle contractions. Mechanisms of paraxanthine’s potential ergogenic effects include (A) an increase in plasma free fatty acids, a source of fuel that the body can utilize to produce energy, (B) a reduction of plasma K+ concentrations which may attenuate the onset of skeletal muscle fatigue, and (C) an increase in calcium ions in the skeletal muscle, which is involved in muscle contractions. 
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