A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Loratadine (Xisimin [Test Treatment]); Drug: Loratadine (Clarityne [Reference Treatment])

Study type: Interventional

Funder types: Industry

Identifiers

NCT03196531

1754415ALY1002 (Other Identifier)

CR108328

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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108 participants in 4 patient groups

Cohort 1: Sequence 1 (ABAB)

Experimental group

Description:

Participants will receive 10 milligram (mg) loratadine (1\*10 mg oral tablet) as Xisimin (Treatment A) on Day 1 of Period 1 and Period 3 and 10 mg loratadine (1\*10 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.

Treatment:

Drug: Loratadine (Clarityne [Reference Treatment])

Drug: Loratadine (Xisimin [Test Treatment])

Cohort 1: Sequence 2 (BABA)

Experimental group

Description:

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.

Treatment:

Drug: Loratadine (Clarityne [Reference Treatment])

Drug: Loratadine (Xisimin [Test Treatment])

Cohort 2: Sequence 1 (ABAB)

Experimental group

Description:

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.

Treatment:

Drug: Loratadine (Clarityne [Reference Treatment])

Drug: Loratadine (Xisimin [Test Treatment])

Cohort 2: Sequence 2 (BABA)

Experimental group

Description:

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.

Treatment:

Drug: Loratadine (Clarityne [Reference Treatment])

Drug: Loratadine (Xisimin [Test Treatment])