Bioavailability study of Fentanyl Citrate

Not Applicable

Completed

• Registration Number: CTRI/2014/10/005091
• Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

â??Healthy, adult, human volunteers of any race within the age range of 18 to 45 years (both inclusive).

â??Willingness to provide informed consent to participate in the study

â??Body Mass Index (BMI) > 18.0 kg/m2 to < 25.0 kg/m2.

â??Volunteers with a systolic blood pressure >= 110 mmHg, diastolic blood pressure >= 60 mmHg, pulse rate >= 60 beats/minute and respiratory rate between 12-20 breaths/minute.

â??Hemoglobin: >=12.0 gm% for male and >=11.5 gm% for female

â??Absence of disease markers of HIV I & II, HBsAg, HCVAb and P24 antigen test.

â??Females of childbearing age must be practicing an acceptable form of birth control for at least six months before screening and continue practicing an acceptable form of birth control during the study, unless have had bilateral oophorectomy or tubal ligation or male partner has had vasectomy.

â??Females of childbearing age agree to use acceptable form of birth control until the drug is washed out from the body i.e. 07 days after last dosing, unless have had bilateral oophorectomy or tubal ligation or male partner has had vasectomy.

â??Subject agrees not to consume MAO-inhibitors during the study.

â??Absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening.

â??Have a normal 12-lead ECG or one with abnormality considered clinically insignificant.

â??Have a normal chest X-ray (P. A. view).

â??Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure.

â??Negative Breath alcohol test at every check in.

â??Non smokers

â??Subject who has passed Naloxone challenge test at screening.

â??Subject whose mouth can be opened with three finger mouth opening.

â??Negative serum β-HCG at the time of screening and at every check in (for females only).

â??Negative urine drug of abuse test (Barbiturates, Benzodiazepines, Opioids, Cocaine, Cannabinoids and Amphetamine, e.t.c.) at screening and at every check-in. (This test will be done at the clinical facility).

Exclusion Criteria

â??History / evidence of allergy or hypersensitivity to Fentanyl or to any of the components of IP or other narcotics.

â??Any major illness in last three months or any significant ongoing chronic medical illness.

â??Recent history of kidney or liver dysfunction.

â??History of depression, mood problems, or suicidal thoughts or behavior. [4]

â??Active deep vein thrombosis, arterial thromboembolic disorders or a history of these conditions.

â??History of or current any gastro-intestinal diseases.

â??History of drug abuse (including barbiturates, benzodiazepines, opioids, cocaine, cannabinoids and amphetamine etc.) within last 3 months.

â??History of neuropsychiatric diseases.

â??History of or currently suffering from any buccal mucosa diseases & mouth ulcer disease or fibrosis in mouth.

â??History of respiratory depression (potentially leading to apnea or respiratory arrest).

â??History of circulatory depression.

â??History of hypotension.

â??History of shock.

â??History of obstructive airways disease or any chronic respiratory disease.

â??History of breast cancer, endometrial cancer or other estrogen-dependent neoplasia, endometriosis and undiagnosed vaginal bleeding (for females only).

â??Volunteers who have received MAO-inhibitors or opioids within 14 days prior to dosing of IP.

â??Xanthine containing food and beverages [chocolates, tea, coffee or cola drinks] and tobacco products (Gutka or Pan masala) consumption at least 48.00 hours prior to check in.

â??Consumption of grapefruit-, grapefruit juice/ products- and poppy- containing food and beverages within at least 48.00 hours prior to every check in.

â??History of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol at least 48.00 hours prior to check in.

â??Participation in any clinical trial within last three months.

â??History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.

â??Donation of blood (one unit or 350 mL or more) within last three months prior to receiving the first dose of investigational products.

â??Use of any prescription drug therapy within two weeks and over the counter (OTC) drugs or herbal products within one week prior to receiving the first dose of study medication and during the study [these includes , diazepam, Epinephrine, neuroleptic agents, CNS depressant drugs (e.g. barbiturates, tranquilizers, opioids and general anesthetics), agents that affect the CYP3A4 activity i.e. strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelifinavir, and nefazodone) and moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, and verapamil)].

â??Pregnant women

â??Breast feeding women

Study & Design

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