A Study to Assess the Bioequivalence of Xisimin (Loratadi... | NCT03196531

ID	Type	Description	Link
1754415ALY1002	Other Identifier	Xian Janssen Pharmaceutical Ltd., China

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: Sequence 1 (ABAB)	Experimental	Participants will receive 10 milligram (mg) loratadine (110 mg oral tablet) as Xisimin (Treatment A) on Day 1 of Period 1 and Period 3 and 10 mg loratadine (110 mg oral tablet) administered as Clarityne (Treatment B) on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration.	Drug: Loratadine (Xisimin [Test Treatment]) Drug: Loratadine (Clarityne [Reference Treatment])
Cohort 1: Sequence 2 (BABA)	Experimental	Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration.	Drug: Loratadine (Xisimin [Test Treatment]) Drug: Loratadine (Clarityne [Reference Treatment])
Cohort 2: Sequence 1 (ABAB)	Experimental	Participants will receive Treatment A on Day 1 of Period 1 and Period 3 and Treatment B on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration.	Drug: Loratadine (Xisimin [Test Treatment]) Drug: Loratadine (Clarityne [Reference Treatment])
Cohort 2: Sequence 2 (BABA)	Experimental	Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Loratadine (Xisimin [Test Treatment])	Drug	Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.	Cohort 1: Sequence 1 (ABAB)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Loratadine	The Cmax is the maximum observed plasma concentration.	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
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) for Loratadine	The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.	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
Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for Loratadine	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.	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	Description	Time Frame
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	From Screening to Day 5 of Period 4 (Approximately 33 days)

Eligibility Module

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

ID	Term
D003533	Cyproheptadine
D003986	Dibenzocycloheptenes
D001567	Benzocycloheptenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011083	Polycyclic Compounds