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

Phase 1

• Conditions: Bioequivalence Study, Healthy, Thai, Volunteers; montelukast, Bioequivalence , Thai

• Registration Number: TCTR20180614001
• Lead Sponsor: International Bio Service Co. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-14
• Study Completion: 2018-08-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 40

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

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 หรือผลิตภัà¸à¸‘์ท่ีมีส่วนผสมของแซนทีนหรือแคเฟอีนเป็น
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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