To study the safety of capsaicin tablets in healthy adult humans

Not Applicable

Completed

• Registration Number: CTRI/2023/03/050250
• Lead Sponsor: Dr Shefali Thanawala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Normal healthy adult human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during

screening and check-in and whose screening is performed within 21 days of check in

Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical

significance

Healthy as documented by the medical history physical examination (including but may not be limited to an evaluation of the cardiovascular gastrointestinal, respiratory,

musculoskeletal and central nervous systems) and vital sign

assessments

Generally healthy as documented by 12-lead electrocardiogram (ECG) X-Ray and clinical laboratory

assessments

Non-smokers or ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months

Willing to consume ovo lacto vegetarian diet

Willing to comply all requirements for this study protocol as well as instructed by the study personnel

Exclusion Criteria

Evidence of allergy or known hypersensitivity to Melatonin or its

inactive ingredients

Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and

pre-existing gallbladder disease.

Any major illness in the last three months or any significant on going

chronic medical illness.

Renal or liver impairment.

Any disease or condition which might compromise the hemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system diabetes psychosis or any other body system

History of alcohol addiction or abuse

Consumption of caffeine and or Xanthiine containing products

cigarette and tobacco containing products for at least 24.00 hours

prior to check-in and throughout the entire study

Positive results for alcohol test prior to check-in of each period.

Subjects who have taken any prescription medications within 14

days prior to study check-in and throughout the study and any over

the counter medicinal products, herbal medications within 07 days

prior to check-in and throughout the study

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the oral pharmacokinetic properties of capsaicinoids 50 and 20 mg capsulesTimepoint: 23 <br/ ><br>00.00, 00.25, 00.50, 00.75.1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 Hours

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolrability of capsaicinoids capsulesTimepoint: 23 <br/ ><br>00.00, 00.25, 00.50, 00.75.1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00 Hours