Clinical trial NCT03151720: A Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared to Clarityne Tablets
Official title: A Single-Dose, Randomized, Open-Label, Two-Treatment, Four-Period, Crossover Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Subjects Compared to Clarityne Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-12
Enrollment: 28
Sex: ALL
Minimum age (years): 20
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 establish the relative bioavailability of Xisimin (loratadine) compared to 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:

* Body mass index (BMI, weight \[kilogram\]/height\^2 \[meter\^2\]) between 19.0 and 26.0 kg/m2 (kilogram per meter square) (inclusive); body weight of male participants not less than 50 kilogram (kg) and body weight of female participants not less than 45 kg
* If a woman, must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (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 urine 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 (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 month after the last dose of study drug

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, or urinalysis at screening or on Day -1 of each treatment period as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening or on Day -1 of each treatment period as deemed appropriate by the investigator
* Clinically significant abnormal chest radiography at screening as deemed appropriate by the investigator
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives and paracetamol within 14 days before the first dose of the study drug is scheduled

Primary outcomes:
measure: Relative Bioavailability of Xisimin Compared With Clarityne
timeFrame: Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Loratadine
timeFrame: Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 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, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 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, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose
measure: Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
timeFrame: From Screening to Day 5 of Period 4 (Approximately 54 days)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service Genaral Hospital
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: