A Bioequivalence Study of 5-mg Montelukast Sodium Chewable Tablets in Healthy Thai Volunteers under Fasting Conditio

Phase 1

• Conditions: Healthy volunteers; Bioequivalence; Montelukast

• Registration Number: TCTR20170516004
• Lead Sponsor: T.O. Chemicals (1979) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-16
• Study Completion: 2017-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1.Male/Female must be 18-55 years of age, body mass index (BMI) = 18-25 kg/m2, inclusive.
2.Must be in good health as determined by medical history, vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 140 mmHg, diastolic blood pressure not lower than 60 or not over 90 mmHg), body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of clinical investigator
3.Screening ECG without clinically significant abnormalities
4.Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasting blood sugar (FBS), blood urea nitrogen (BUN), Creatinine (Cr) analysis and liver function test (aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin and alkaline phosphatase (ALP)) must be within the normal range or showing no clinically significant abnormalities in the opinion of clinical investigator.
5.Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of clinical investigator.
6.Must have serum HbsAg seronegative and anti-HCV negative
7.Female subjects must have serum β-HCG negative.
8.Female subject who is childbearing potential agrees to use an acceptable birth control method from visit 1 to the follow up visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD) and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the follow up visit. Hormonal contraceptives are not acceptable.
9.Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea))
10.Female subjects must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing prior to dosing at period I and period II.
11.Non-smokers (never smoked or no smoking within the previous 1 year)
12.Refrain from using herbal medications, dietary supplements (e.g., St. John’s Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of study drug (Study Day 1). Subjects must agree to refrain from these items until the last collection time-point of period II.
13.Subjects must have ended any medications at least 30 days prior to Study Day 1 and agree to continue their refraining throughout the follow up period.
14.Subjects must refrain from drinking caffeine and alcohol for at least 72 hours prior to Study Day 1 and agree to continue their refraining throughout the last collection time-point of period II.
15.Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria

1.Known hypersensitivity to montelukast and its components
2.Past medical history of moderate to severe hepatic and renal insufficiency, biliary cirrhosis or biliary obstruction, primary hyperaldosteronism, bilateral renal artery stenosis.
3.Subject has a history of any illness that, in the opinion of the investigator, might confound the result of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
4.Have history of drug abuse (in the opinion of the investigator, as judged by medical history) in the last 12 months.
5.Have positive urine drug abuse testing (methamphetamine (Meth), morphine (Mor), tetrahydrocannabinol (THC), cocaine (Coc) and methylenedioxy methamphetamine (MDMA)) at screening visit or before dose administration at each period.
6.Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
7.Have positive alcohol breathing test at screening visit or before dose administration at each period.
8.Female subject is pregnant or breast feeding.
9.Difficulties fasting or consuming standard meals.
10.Donation or loss of whole blood:
a.≥ 50 mL and ≤ 499 mL within 30 days prior to dosing
b.≥ 500 mL within 56 days prior to dosing.
11.Participation in any investigation drug study within 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter: Cmax, AUCs 0.0, 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10.0, 12, 14, 16, 24 hours post-dose Montelukast in plasma

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A