Healthy male and female volunteers
Conditions
Interventions
Darunavir 600 mg immediate-
release tablets,Darunavir 600 mg immediate-
Experimental Drug,Active Comparator Drug
Darutab,PREZISTA
Sponsors
The Government Pharmaceutical Organization
The Government Pharmaceutical Organization
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: a) Non-smokers, Normal, Healthy, adult, human, subjects between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India. b) Having a Body Mass Index (BMI) between 18.0 and 25.0 (both inclusive), calculated as weight in kg/height in m2. c) 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 (P/A view). d) Able to understand and comply with the study procedures, in the opinion of the investigator. e) Able to give voluntary written informed consent for participation in the trial. f) In case of female subjects: i. Surgically sterilized at least 06 months prior to study participation; Or ii. 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 iii. Serum pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: a) Known hypersensitivity or idiosyncratic reaction to Darunavir, Ritonavir or any of the excipients or any other related drug. b) 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. c) Ingestion of a medicine (CYP3A4 substrates, alfuzosin, cisapride, colchicine, dronedarone, dihydroergotamine, ergotamine, lovastatin, methylergonovine, oral midazolam, pimozide, ranolazine, rifampin, sildenafil (for treatment of pulmonary arterial hypertension), simvastatin, St. John’s Wort, and triazolam including herbal remedies) at any time within 14 days prior to the first ritonavir dosing in period I. In any such case subject selection will be at the discretion of the Principal Investigator. d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria. e) The presence of clinically significant abnormal laboratory values during screening. f) Consumption of Grapefruits or its products within a period of 72 hours prior to first ritonavir's administration in period-I. g) 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 first ritonavir's administration in period-I. h) Smokers or who have smoked within last 06 months prior to start of the study. i) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. j) History or presence of seizure or psychiatric disorders. k) A history of difficulty with donating blood. l) Difficulty in swallowing oral solid dosage form like tablet or capsule. m) Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product within 90 days prior to receiving the first ritonavir's administration in period-I. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study. Note: If subject had participated in a study or donated blood in which blood loss was ≤ 200 mL, subject may be dosed 60 days after the last sample of previous study or after the blood donation. n) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. o) A positive test result for HIV (I and/or II) antibody. p) An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the first study drug in Period-I. In any such case subject selection will be at the discretion of the Principal Investigator. q) Nursing mothers (females).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90%CI of pharmacokinetic parameters 24 blood sampling time points Bioanalysis and pharmacokinetic data analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events/Severe adverse events At least 24 observations/examinations for each subject Observation/physical and biochemical examination | — |
Countries
India
Contacts
Public ContactSejal Patel
Lambda Therapeutic Research Ltd.
Outcome results
None listed