A single dose, randomized, open-label, two-way crossover Bioequivalence study of Duloxetine delayed release capsules USP 60 mg relative to Cymbalta® (60 mg hard gastro-resistant capsules duloxetine) in healthy Thai volunteers under fasting and fed conditions
- Conditions
- Healthy Volunteer
- Registration Number
- TCTR20200313007
- Lead Sponsor
- International Bio Service Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 32
1. Healthy Thai male or female subjects between the ages of 18 to 55years.
2. Body mass index between 18.0 to 30.0 kg/m2.
3. Non-smoker and/or non-consumer of nicotine containing products.
Non-smoker means any subject who has never smoked or stopped for at least 90 days whereas non-consumer of nicotine containing products means any subject who stopped nicotine containing product consumption for at least 90 days.
4. 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.
5. Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
6. 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 check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in 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 check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-child bearing potential must meet at least one of the following criteria prior to check-in in Period 1:
•Postmenopausal for at least 1year or
•Surgicallysterile(bilateraltuballigation,bilateraloophorectomyor hysterectomy) at least 6months
7. Male subjects who are willing or able to use effective contraceptive e.g.condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
8. Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
1. History of allergic reaction or hypersensitivity to duloxetine or to any of the excipients of the product
2. History or evidence of clinically significant renal, hepatic, gastrointestinal,
Hematological (e.g.anemia), endocrine (e.g. hyper/ hypothyroidism), pulmonary or respiratory(e.g.asthma),cardiovascular,psychiatric (e.g.anxiety disorder, depression, mania), 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 chronic pain such as chronic lower back pain, peripheral
Neuropathic pain, fibromyalgia or osteoarthritis
4. History of suicidal thoughts, behavior or suicide attempts in the past 30 days prior to screening or during enrollment in the study
5. History of problems with swallowing tablet or capsule
6. History of sensitivity to heparin or heparin-induced thrombocytopenia
7. History or evidence of fructose intolerance, glucose-galactose malabsorption or
sucrose-isomaltase insufficiency
8. Reports difficulty fasting or consuming standardized meals
9. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy,
gastritis or duodenal or gastric ulceration other than appendectomy
10. History of vomiting or diarrhea within 24 hours prior to check-in in each period
11. Historyorevidenceofdrugaddictorinvestigationwithurinesampleshowsa
Positive test for drug of abuse (morphine, marijuanaor methamphetamine)
12. Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day or check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest forat least 5 minutes each. The last measurement values hould be used to determine the subject’s eligibility.
13. Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per Minute on screening day or check-in day. If abnormal pulse rate detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject’s eligibility.
14. 12-lead ECG demonstrating QTc >450msec, a QRS interval >120msec 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.
15. Investigation with blood sample shows positive test for HBsAg.
16. Abnormal liver function, ≥1.5times of upper normal limit of reference range for
ALT,AST or bilirubin levels at screening laboratory test
17. Have renal creatinine clearance (Clcr) <30 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the
Screening laboratory test
18. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drinkis defined as 360 mL of beer or 150 m
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duloxetine level in plasma 0-72 hours ng/ml
- Secondary Outcome Measures
Name Time Method Body temperature 3, 7 and 12 hours Celsius,Blood pressure 4, 5, 6, 8 and 9 hours mmHg,pulse rate 4, 5, 6, 8 and 9 hours BPM