Healthy male and female volunteers
Conditions
Interventions
Quetiapine 100 mg immediate-
release tablets,Quetiapine 100 mg immediate-
Experimental Drug,Active Comparator Drug
QUAPINE,Seroquel
Sponsors
The Government Pharmaceutical Organization
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: i. Non-smokers , healthy, adult, human subjects between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India. ii. Having a Body Mass Index (BMI) between 18.0 and 25.0 (both inclusive), calculated as weight in kg/height in m2. iii. Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (postero-anterior view). iv. Able to understand and comply with the study procedures, in the opinion of the investigator. v. Able to give voluntary written informed consent for participation in the trial. vi. In case of female subjects: Surgically sterilized at least 06 months prior to study participation; Or If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. And Serum pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: i. Known hypersensitivity to Quetiapine or any related drug or its excipients. ii. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. iii. Sitting blood pressure less than 110 /70 mm Hg and pulse rate less than 60 or more than 100 beats per minute at the time of screening. iv. Pre-existing psychiatric disease at the time of screening. v. Presence of orthostatic hypotension at the time of screening. vi. If the QTc interval will be more than 450 ms on ECG measurement at the time of screening. vii. Ingestion or Use of any medication [prescribed medication & over the counter (OTC) medication including herbal remedies, CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and CYP3A4 inducers (e.g, phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.)] at any time in 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator. viii. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria. ix. Consumption of grapefruits or its products within a period of 72 hours prior to receiving the study in period I. x. Smokers or who have smoked within last 06 months prior to start of the study. xi. A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine in period I. xii. The presence of clinically significant abnormal laboratory values during screening. xiii. Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans. xiv. History or presence of psychiatric disorder xv. A history of difficulty with donating blood. xvi. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product within 90 days prior to receiving the first dose of study drug. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study. xvii. A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. xviii. A positive test result for HIV antibody (I & II). xix. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study drug in period I. In any such case subject selection will be at the discretion of the Principal Investigator. xx. Nursing mothers (for female subjects). xxi. A history of suicidal attempt and/or present positive result of suicidal assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90%CI of pharmacokinetic parameters derived from plasma concentration-time profile 23 blood sampling time points from 0-48 hours post dose Bioanalysis of plasma samples and pharmacokinetic data analysis derived from drug plasma concentrati | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events/Severe adverse events At screening, after check-in, pre-dose and at 2, 4, 6, 8, 10, 24, 36, and 48 hours post-dose Physical and biochemical examination eg. vital sign, oral body temperature, blood pressure, pulse ra | — |
Countries
India
Contacts
Public ContactAdarsh Garg
Lambda Therapeutic Research Ltd.
Outcome results
None listed