None listed
Conditions
Interventions
Intervention1: 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 lea
Sponsors
Dr AKBAR WAJID
Eligibility
Inclusion criteria
Inclusion criteria: 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/m ) (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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: The safety of the subjects will be monitored during the study The adverse events will be reported accordingly | — |
Countries
India
Contacts
Public ContactDr Mallu Maheswara Reddy
Jeevan Scientific Technology Ltd
Outcome results
None listed