Clinical trial NCT03196531: A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets
Official title: A Single-Dose, Randomized, Open-Label, Two-Treatment, Four-Period, Crossover Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Subjects Compared With Clarityne Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.


Eligibility criteria: Inclusion Criteria:

* If a woman, must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (for example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry, throughout the study, and for 1 month after the last dose of study drug
* If a woman, must have a negative serum pregnancy test at screening and a negative serum pregnancy test on Day -1 of each treatment period
* If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug
* If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (for example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Must agree to continue using an appropriate method of birth control during the study and for 3 months after the last dose of study drug
* Body mass index (BMI, weight \[kilogram\]/height\^2 \[meter\^2\] {\[kg\]/height2 \[m\]2}) between 19.0 and 26.0 kilogram per meter square (kg/m2) (inclusive); body weight of male participants not less than 50 kilogram (kg) and body weight of female participants not less than 45 kg

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), gastrointestinal disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, or 12-lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, or vital signs at screening or on Day -1 of each treatment period as deemed appropriate by the investigator
* Use of any prescription or Over-the-counter (OTC) drug (including vitamins and botanical supplements such as hypericum perforatum \[St. John's wort\]), except for oral contraceptives, within 14 days prior to scheduled administration of the first dose of study drug
* Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C antibodies or syphilis serum test

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Loratadine
timeFrame: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) for Loratadine
timeFrame: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for Loratadine
timeFrame: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h postdose
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: From Screening to Day 5 of Period 4 (Approximately 33 days)
Other outcomes:
Locations:
city: ChangSha
country: China
facility: Xiangya Hospital Central South University
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: