Not Yet RecruitingPhase 1ACTRN12624000019505

A Bioequivalence study of loratadine 5mg Chewable Tablets of AFT Pharmaceuticals compared with Children's Claratyne® Grape 5mg Chewable Tablets in healthy human adults under fasting conditions.

A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Two-Way Crossover, Bioequivalence Study of Loratadine 5mg Chewable Tablets of AFT Pharmaceuticals, Australia Compared with Children's Claratyne® Grape 5 mg Chewable Tablets in Healthy Human Adult Subjects Under Fasting Conditions.

Sponsor

AFT Pharmaceuticals Ltd

Enrollment

56 participants

Start Date

Jan 21, 2025

Study Type

Interventional

Conditions

Allergies

Summary

This study is designed as a bioequivalence study to compare the rate and extent of absorption of Loratadine 5mg Chewable Tablets of AFT Pharmaceuticals, Australia with Children's Claratyne® Grape 5 mg Chewable Tablets of Bayer Australia Ltd. in normal, healthy, adult human subjects. This study will include 56 healthy volunteers and will be conducted under fasting conditions. The study aims to demonstrate that Loratadine 5mg Chewable Tablets of AFT Pharmaceuticals, Australia is absorbed and cleared from the body in the same way and has a similar safety profile to Children's Claratyne® Grape 5 mg Chewable Tablets of Bayer Australia Ltd. It is hypothesized that both products will have similar absorption, clearance, and safety profiles.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria16

A subject fulfilling all of the following criteria will be included in the study:
Willing to provide written informed consent to participate in the study, and an ability to comprehend the nature and purpose of the study;
Subjects with healthy oral cavity.
Willing to be available for the entire study duration and to comply protocol requirements;
Normal, healthy, adult human subject of 18 to 45 years (both inclusive) of age and weight greater than or equal to 50 Kg;
Body mass index in the range of 18.50 to 30.00 kg/m2 (both inclusive);
Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and medical examination at the time of screening as well as check-in of each study period;
Normal or clinically non-significant laboratory values as determined by haematological, biochemistry tests and urine analysis;
Normal or clinically non-significant 12-lead ECG recording;
Non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day;
Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to dosing until last sample collection in each study period;
Willing to abstain from grapefruit or its juice at least 72.00 hours prior to dosing until last sample collection in each study period;
Willing to abstain from smoking or chewing any tobacco containing product and xanthine or its derivative containing food or beverages (e.g., chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to dosing until last sample collection in each study period;
For female subjects:
Negative urine pregnancy test during screening and negative serum ß-hCG test at the time check-in of each study period;
Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or use of acceptable birth control methods for at least 15 days before 1st dosing till 15 days post last-dose [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].

Exclusion Criteria19

A subject meeting any one of the following criteria will be excluded from the study:
Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs;
Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), haematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
Any major illness or hospitalized within 90 days prior to the first dosing;
Requiring medication for any ailment having enzyme-modifying activity within one month prior to first dosing until last blood sample collection in the study;
Use of any depot injection or an implant of any drug within 03 months prior to first dosing until last blood sample collection in the study;
Use of any prescribed medication or OTC products (including herbal medicines and vitamin supplements) within 30 days prior to dosing of period I and throughout the study;
Subject who can’t hold the saliva in mouth for 01.00 hour.
Difficulty in chewing and swallowing IMPs
Subjects which having teeth disorders i.e., periodontitis, tooth decay, gingivitis, teeth arrangement, dry mouth, mouth ulcer etc.
History or presence of significant gastric and/or duodenal ulceration;
Use of any recreational drug or history of drug addiction;
Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first dosing;
Positive breath alcohol and urine drugs of abuse tests during check-in of each study period;
Positive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies;
Pregnant or lactating or nursing female subjects;
Female subjects using hormonal contraceptive (either oral/implants);
History of allergy or hypersensitivity intolerance to Loratadine and Desloratadine or related group of drugs or its formulation excipients which, in the opinion of a Principal Investigator, would compromise the safety of the subject or the study;
History of difficulty in accessibility of veins in arms.

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Interventions

Each participant will be randomly allocated to receive a single dose of each of the Test product (T), and the Reference product (R) under fasting conditions in a two-way crossover sequence: Test pr

Each participant will be randomly allocated to receive a single dose of each of the Test product (T), and the Reference product (R) under fasting conditions in a two-way crossover sequence: Test product (T): Loratadine 5mg Chewable Tablets manufacture for AFT Pharmaceuticals, Australia Administration: Following an overnight fast of at least 10 hours, subjects will be dosed one tablet at ambient temperature in an upright sitting position as per the randomization schedule. Subjects will be housed in Genecht's Clinical Pharmacology Unit where dosing and administration will take place. The dosing and administration process as detailed below will be conducted by either the Principal Investigator or a research personnel designated by the Principal Investigator: •Subject will wet their mouth with 20 ± 2 ml of water by swallowing, just 20 seconds before dosing. •Subject will chew the tablet slowly and thoroughly. •Mouth check will be performed immediately after the subject indicated that the tablet was completely chewed •Once this is confirmed, the subject will be instructed to swallow the chewed tablet mass. •All the subjects shall be instructed not to spit the saliva and phlegm until one hour after dosing. •Subjects will be instructed to remain in upright posture for at least 04.00 hours post-dose except for essential reasons (e.g., use of washroom) or study procedures. Compliance for dosing will be assessed by a thorough check of the oral cavity with a torch and disposable tongue depressor immediately after dosing. There will be two study periods separated by a washout period of at least 14 days will be maintained between each dosing period. Subjects will be checked out after 24 hours post-dose during each study period.