None listed
Conditions
Interventions
Intervention1: Formulation#1: 5mg montelukast sodium (GW483100)chewable tablet Manufactured by Piramal Pharmaceutical Development Services, India for GSK: Each chewable tablet contains 5 mg montelukas
Sponsors
GlaxoSmithKline Research and Development Limited
Eligibility
Inclusion criteria
Inclusion criteria: Type of Subject and Diagnosis Including Disease Severity • Healthy as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. • A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. 3. Weight • Body weight >= 50 kg and BMI within the range 19 â?? 24.9 kg/m2 (inclusive). 4. Sex • Male • Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies. Non-reproductive potential defined as • Pre-menopausal females with one of the following • Documented tubal ligation • Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion • Hysterectomy • Documented bilateral oophorectomy • Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause [refer to laboratory reference ranges for confirmatory levels]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment • Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until [at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer] after the last dose of study medication and completion of the follow-up visit.INFORMED CONSENT Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion criteria
Exclusion criteria: • The QTc is the QT interval corrected for heart rate according to Bazettâ??s formula (QTcB), Fridericiaâ??s formula (QTcF), and/or another method, machineread or manually over-read • No concomitant medications should be taken by the subject while participating in the study • History of sensitivity to heparin or heparin-induced thrombocytopenia A. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, subjects with presence of hepatitis B core
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the relative bioavailability of montelukast sodium following administration of two candidate chewable test formulation tablets of montelukast sodium (GW483100; 5mg) relative to reference montelukast sodium (Singulair Chewable; 5mg) tablet in healthy human subjects under fasting conditionsTimepoint: Twenty (20) blood samples (1 x 5 mL) will be collected in pre-labelled K2EDTA vacutainers, during each treatment period. Single venous blood sample will be withdrawn at pre-dose (0.00) and at 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma PK parameters: tmax, %AUCex and t½ To monitor the safety and tolerability following administration of two candidate chewable test formulation tablets of montelukast sodium (GW483100; 5mg) relative to reference montelukast sodium (Singulair Chewable; 5mg) tablet in healthy human subjects under fasting conditions. Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, review of adverse events and clinical laboratory safety data. Timepoint: Twenty (20) blood samples (1 x 5 mL) will be collected in pre-labelled K2EDTA vacutainers, during each treatment period. Single venous blood sample will be withdrawn at pre-dose (0.00) and at 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours post-dose. | — |
Countries
India
Contacts
Public ContactMaddela Rambabu
Piramal Clinical Research
Outcome results
None listed