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، جلد ۵، شماره ۴، صفحات ۲۱-۲۷
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| عنوان فارسی |
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| چکیده فارسی مقاله |
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| کلیدواژه‌های فارسی مقاله |
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| عنوان انگلیسی |
Bioequivalence Study of Two Formulations of Tramadol Capsules in Healthy Myanmar Volunteers |
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| چکیده انگلیسی مقاله |
Tramadol is one of the most commonly used analgesics, thanks to its efficacy and safety. It is widely used in Myanmar for postoperative and cancer pain control. The use of generic drugs has been steadily increasing worldwide, mostly in developing countries. Generic drugs should have efficacy and safety comparable to their innovators or other approved generic products. This study aims to compare the bioequivalence of locally producing, Tramadol BPI® capsule (test product) with the Tramazac® capsule (reference product) in healthy Myanmar volunteers. The bioequivalence was determined in 16 healthy Myanmar volunteers after a single oral administration of 100 mg tramadol (under fasting condition) in a randomized, open-label, two-period, and two-treatment crossover study with a two-week washout period. Blood samples were collected at specified times, and plasma tramadol concentrations were measured with a validated high-performance liquid chromatography method with a fluorescence detector. Pharmacokinetic parameters were determined using the plasma concentration-time data in a non-compartmental model. The analysis of variance of the logarithmically transformed parameters (Cmax, AUC0–t, and AUC0–∞) revealed no sequence, period, and formulation effects between the test and reference products. Significant differences were found between the subjects within the sequence for both AUC0–t, and AUC0–∞, indicating a substantial inter-subject variation. The geometric mean ratio of test/reference and their 90% confidence interval were within the ASEAN bioequivalence acceptance interval of 80% to 125%. Tramadol BPI® and Tramazac® capsules, after a single oral administration of 100 mg, were bioequivalent in respect of their rate and extent of absorption under fasting condition. |
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| کلیدواژه‌های انگلیسی مقاله |
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| نویسندگان مقاله |
| Ye Htut Linn
Department of Pharmacology, University of Medicine, Yangon. No. 245, Myoma Kyaung Street, Lanmadaw Township, Yangon, Myanmar
| Myat Myat Soe
Department of Pharmacology, University of Medicine, Magway
| K Khine Thu
Department of Pharmacology, University of Medicine, Yangon
| Thida Tun
Department of Pharmacology, University of Medicine, Yangon
| Mi Kun Kaw San
Department of Pharmacology, University of Medicine, Yangon
| Nyein Chan Pyae
Department of Pharmacology, University of Medicine, Yangon
| Nu Nu Aye
Department of Pharmacology, University of Medicine, Yangon
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| نشانی اینترنتی |
http://pbr.mazums.ac.ir/browse.php?a_code=A-10-764-1&slc_lang=en&sid=1 |
| فایل مقاله |
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| کد مقاله (doi) |
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| زبان مقاله منتشر شده |
en |
| موضوعات مقاله منتشر شده |
فارماکولوژی |
| نوع مقاله منتشر شده |
پژوهشی |
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