Bioequivalence study of Darifenacin 15 mg proloned-release tablets in healthy Thai volunteers

Not Applicable

Completed

• Conditions: Bioequivalenc of generic Darifenacin PR

• Registration Number: TCTR20170512004
• Lead Sponsor: All Research Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-12
• Study Completion: 2018-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.Healthy Thai male and female volunteers aged between 18 and 55 years.
2.The Body Mass Index (BMI) ranges from 18 to 25 kg/m2.
3.Determined healthy by medical history, physical examination and vital signs
4.The results of the clinical laboratory tests are within clinically acceptance limits i.e., blood urea nitrogen (BUN), serum creatinine, AST, ALT, total bilirubin, alkaline phosphatase, blood potassium, sodium, calcium, chloride, fasting blood sugar and hematology examinations including differential blood counts and HBsAg test. Some of the clinical laboratory values that out of the normal range will be carefully considered by clinical investigator.
5.Male volunteers who are surgically sterile or agree to use an effective contraception throughout the study and until the completion of the study.
6.Willing to participate in the study and signed the informed consent form.

Exclusion Criteria

1.History or evidence of allergy or hypersensitivity to darifenacin or any of the excipients of this product or any related drugs.
2.History or evidence of allergy or hypersensitivity to heparin.
3.History or evidence of hypertension (systolic BP 140 mmHg, diastolic BP 90 mmHg) or hypotension (systolic BP <90 mmHg, diastolic BP <60 mmHg).
4.History or evidence of gastrointestinal, hepatic, renal, cardiovascular, hemato-logical disease or allergic disease or bronchial asthma or any disease that may affect the bioavailability of drug.
5.ECG results show malignant arrhythmia, or QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening or HR <40 bpm, or HR > 110 bpm. If QTc exceeds 450 msec, or QRS exceeds 120 msec, two more ECG tests must be performed and the average of the three QTc or QRS values should be used to determine the subject’s eligibility.
6.History of chronic or debilitating diseases.
7.Positive HBsAg tests.
8.History of alcoholism or drug abuse.
9.Positive urine drug abuse tests (Benzodiazepines, Methamphetamine and Opi-ates).
10.History of regular alcohol consumption (more than 1 time a week) or alcohol consumption within 7 days prior to the study drug administration and until the completion of the study.
11.History of smoking more than 10 cigarettes/day, or moderate smokers (less than 10 cigarettes/day) and could not quit at least 7 days prior to the study drug administration and until the completion of the study.
12.Tea/coffee or caffeine- or xanthine-containing beverage consumption within 7 days prior to the study drug administration and until the completion of the study.
13.Grapefruit juice or grapefruit-containing products consumption within 7 days prior to the study drug administration and until the completion of the study.
14.Use of any prescription drugs or over-the-counter (OTC) drugs or herbal medi-cines within 30 days or vitamins or food supplements within 14 days prior to the study drug administration or use hormonal methods of contraception with-in 28 days (discontinuation for at least 6 months is required for Depo-Provera use) prior to receiving the first dose of the study medication and until the com-pletion of the study.
15.Blood donation or blood loss over 350 mL within 90 days preceding the admission into the study.
16.Participation in any clinical studies within 90 days preceding the admission into this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax, AUC0-t and AUC0-inf 0, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 24, 48 and 72 h Drug concentration in Plasma

Secondary Outcome Measures

Name	Time	Method
AUC0-t/AUC0-inf, Tmax, T1/2 and Kel 0, 1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 24, 48 and 72 h Drug concentration in Plasma