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A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of MONTELUKAST TABLETS 10 mg and Reference Product (S1NGULAIR 10 mg (montelukast sodium, MSD)) in Healthy Thai Volunteers under Fasting Conditions

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of MONTELUKAST TABLETS 10 mg and Reference Product (S1NGULAIR 10 mg (montelukast sodium, MSD)) in Healthy Thai Volunteers under Fasting Conditions

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180614001
Enrollment
40
Registered
2018-06-14
Start date
2018-07-31
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence Study&#44

Interventions

MONTELUKAST TABLETS 10 mg&#44
containing 10.4 mg montelukast sodium which is equivalent to montelukast 10.0 mg per film&#45
coated tablet,S1NGULAIR 10 mg (montelukast sodium&#44
MSD)&#44
Reg. No. 1C 51/55 (N)&#44
containing 10.4 mg montelukast sodium which is equivalent to 10.0 mg of free acid per film&#45
coated tablet&#44
manufactured by Merck Sharp & Dohme Limited&#44
Shotton Lane&#44
Cramlington&#44
Northumberland NE23 3JU&#44
England and imported by MSD (Thailand) Ltd.&#44
Bangkok&#44
Thailand.
Active Comparator Drug,Active Comparator Drug
montelukast 10.0 mg film&#45
coated tablet (test product),montelukast 10.0 mg film&#45
coated tablet (Reference product)

Sponsors

International Bio Service Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1 Healthy Thai male or female subjects between the ages of 18 to 55 years. 2 Body mass index between 18.0 to 30.0 kg/m2. 3 Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4 Non-pregnant woman (negative pregnancy test) and not currently breast feeding. 5 Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1: •Postmenopausal for at least 1 year or •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6 Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study in Period 2. 7 Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.

Exclusion criteria

Exclusion criteria: 1 History of allergic reaction or hypersensitivity to montelukast or related structure or any of the components of the product 2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. thyroid), pulmonary or respiratory (e.g. asthma), cardiovascular, psychiatric, neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3 History or evidence of rash or vasculitic rash 4 History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 5 History of problems with swallowing tablet or capsule 6 History of sensitivity to heparin or heparin-induced thrombocytopenia 7 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 8 History of preceding diarrhea within 24 hours prior to admission in each period 9 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 10 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject’s eligibility. 11 Investigation with blood sample shows positive test for anti-HIV, anti-HCV, VDRL or HBsAg 12 Investigation with blood sample shows eosinophil is higher than upper normal limit of reference range at screening laboratory test 13 Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 14 History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in Period 2 15 History or evidence of alcoholism, regular alcohol consumption or alcohol containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in Period 2 16 History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in Period 2 มีประวัติหรือหลักฐานการด่ืมชา กาแฟ หรือผลิตภัณฑ์ท่ีมีส่วนผสมของแซนทีนหรือแคเฟอีนเป็น ประจ าและไม่สามารถหยุดอย่างน้อย 7 วันก่อนเข้าพักและต่อเนื่องไปจนถึงการเก็บตัวอย่างครั้ง สุดท้ายในระยะการศึกษาท่ี 2 17 History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collectio

Design outcomes

Primary

MeasureTime frame
montelukast plasma concentrations 0,0.25,0.5,0.75,1,1.33,1.67,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.33,4.67,5,5.5,6,8,10,12,16,24,36 hr. Cmax and AUC0-36—

Secondary

MeasureTime frame
montelukast plasma concentrations 0,0.25,0.5,0.75,1,1.33,1.67,2,2.25,2.5,2.75,3,3.25,3.5,3.75,4,4.33,4.67,5,5.5,6,8,10,12,16,24,36 hr. Tmax , t1/2 and lamda z—

Countries

Thailand

Contacts

Public ContactUthai Suvanakoot

International Bio Service Co., Ltd

uthai.s@chula.ac.th+66 2 441 5211

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026