None listed
Conditions
Interventions
Intervention1: Levocetirizine dihydrochloride 5 mg liquid gel capsules: Test product 1 (once in each period)
Intervention2: Levocetirizine dihydrochloride 5 mg liquid gel capsules: Test product 2 (onc
Sponsors
Opella Healthcare Group SAS
Azidus Laboratories limited
Eligibility
Inclusion criteria
Inclusion criteria: Male and female healthy subjects, between 18 and 55 years of age. Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m, inclusive. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). Vital signs after 10 minutes resting in supine position within the following range: systolic blood pressure (SBP): 100 - 139 mmHg diastolic blood pressure (DBP): 60 – 89 mmHg heart rate (HR): 60 -100 bpm. Standard 12-lead electrocardiogram (ECG) parameters in the following ranges; 120 ms PR less than 220 ms, QRS less than 120 ms, QTcF less than or equal to 450ms for males and QTcF less than or equal to 470ms for females and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant. Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects. Females of childbearing potential (pre-menopausal female biologically capable of becoming pregnant) or not documented post-menopausal (menopause is defined as being amenorrheic for at least 1 year with plasma FSH level more than 30 UI/L) who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last IMP (Investigational Medicinal Product) administration: Intra-uterine contraceptive device placed at least 4 weeks prior to IMP administration. Male condom with intravaginally applied spermicide starting at least 21 days prior to IMP administration. Hormonal contraceptives starting at least 4 weeks prior to IMP administration and must agree to use the same hormonal contraceptive throughout the study. Sterile male partner (vasectomized since at least 6 months). Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, an adequate contraception for study period duration. Having given written informed consent prior to undertaking any study related procedure. Not under any administrative or legal supervision
Exclusion criteria
Exclusion criteria: Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood forming organs. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing. Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure =20mmHg within 3 minutes when changing from supine to standing position. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Presence or history of hypersensitivity to levocetirizine or to any of the excipients. History or presence of drug or alcohol abuse (alcohol consumption more than 14 units per week [1 unit of wine, 360 mL of beer, or 45 mL of 40% alcohol]). Smoking regularly more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). If female, pregnancy (defined as positive serum pregnancy test), or breast-feeding. Any medication (including St John’s Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Refusal to abstain from food for at least ten (10.00) hours prior to receiving the high-fat and high-calorie breakfast and for at least four (04.00) hours post-dose, in each study period. Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. Any subject enrolled or having participated, in any other clinical study involving an IMP or in any other type of medical research, and is still in the exclusion period according to applicable regulations. Any subject who cannot be contacted in case of emergency. Any subject who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study. Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab). Positive result on urine drug of abuse (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). Positive alcohol breath test. Any contraindications to levocet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of a new levocetirizine dihydrochloride 5 mg liquid gel capsules formulation versus the marketed Xyzal® Allergy 24HR (levocetirizine dihydrochloride) 5 mg Film-coated tablets (Comparator) in fasting condition. To assess the effect of food on the new levocetirizine dihydrochloride 5 mg liquid gel capsules formulationTimepoint: 00.00 (Pre-dose), 00.17, 00.33, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 12.00, 24.00, 36.00 and 48.00 To assess the effect of food on the new levocetirizine dihydrochloride 5 mg liquid gel capsules formulation | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the clinical safety of test and comparator levocetirizine dihydrochloride 5 mg Film-coated tablets and liquid gel capsules.Timepoint: 00.00 (Pre-dose), 00.17, 00.33, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 06.00, 08.00, 12.00, 24.00, 36.00 and 48.00 | — |
Countries
India
Contacts
Public ContactS Sathish Kumar
Azidus Laboratories Ltd
Outcome results
None listed