None listed
Conditions
Interventions
Intervention1: Bilastine + Dextromethorphan Hydrobromide + Phenylephrine Hydrochloride: Bilastine
3.3mg + Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride
5mg/5mL Syrup
Control Inter
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, non-smoking, non-alcoholic human subjects (Male and/or non-pregnant, non-lactating female) aged between 18 and 45 years (inclusive of both). 2. Female of childbearing potential must have a negative urine pregnancy test performed within 21 days prior to initiation of the study. Female subject must have a negative serum beta human chorionic gonadotropin (ß-HCG) pregnancy test prior to check-in of each period. They must be using an acceptable form of contraception. 3. For female of childbearing potential, acceptable forms of contraception include the following: i. Non-hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period and for 07 days following last dose of the study medication, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study 4. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months. 5. Subjects with a BMI between 18.50-30.00 kg/m2 (inclusive of both) and weight not less than 50.00 kg. 6. Subjects in normal health as determined by personal medical history, clinical examination including vital signs and clinically acceptable results of laboratory examinations (including serological tests). 7. Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording. 8. Subjects having a normal or clinically not significant chest X-Ray (P/A view). 9. A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine). 10. A negative alcohol urine test or alcohol breath test result. 11. Subject able to communicate effectively and provide their informed consent. 12. Subjects willing to adhere to the protocol requirements as evidenced by informed consent approved by ethics committee. 13. Subjects that can provide adequate evidence of their identity. 14. Availability of volunteer for the entire study duration. 15. Ability to fast for at least 10.00 hours and consume high-fat high-calorie non vegetarian breakfast and standard meals. 16. Subject agreeing to use appropriate contraceptive measures including practice abstention or contraception or Double Barrier method during study and 07 days after completion of study
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Bilastine and/or Dextromethorphan hydrobromide and/or Phenylephrine hydrochloride or to related drugs or any component of this medication. 2. Incapable of understanding the informed consent information. 3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study. 5. History or presence of seizure or psychiatric disorders. 6. History or presence of smoking or consumption of tobacco products. 7. History or presence of alcoholism or drug abuse. 8. History or presence of asthma, urticaria or other allergic reactions. 9. History or presence of gastric and/or duodenal ulceration. 10. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion. 11. History or presence of cancer. 12. Difficulty with donating blood 13. Use of any prescribed medication (including herbal remedies and vitamins) during the two weeks before the start of the study or OTC medicinal products during one week prior to study initiation and throughout the study. 14. Use of ketoconazole, erythromycin, diltiazem, lorazepam, monoamine oxidase inhibitors (MAOIs), CYP2D6 inhibitors, sympathomimetic amines, beta-blockers, other antihypertensives, tricyclic antidepressants, ergot alkaloids, digoxin and cardiac glycosides, warfarin and other coumarins) during the two weeks before the start of the study and throughout the study. 15. Subject consumed caffeine and/or xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), grapefruit and/ or its juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study. 16. Major illness during the 90 days prior to check-in. 17. Participation in a drug research study within 90 days prior to check-in. 18. Donation of blood within 90 days prior to check-in. 19. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL. 20. History or presence of easy bruising or bleeding. 21. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study. 22. Pregnant woman and nursing mothers. 23. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used oral hormonal contraceptives within 14 days before dosing. 24. Woman of child bearing age who do not agree to follow a reliable method of contraception during study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of comparative bioavailability will be based on 90% confidence intervals for ratio (test/reference) of geometric least square means for Ln-transformed AUC0-t of Bilastine.Timepoint: at least 11 days from the day of check-in of the first period till the end of the second period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment the safety of the test product as compared to the reference productTimepoint: at least 11 days from the day of check-in of the first period till the end of the second period. | — |
Countries
India
Contacts
Public ContactMr Umakant Ghodke
Synergen Bio PVt Ltd
Outcome results
None listed