NL-OMON41936已完成不适用
A Phase I study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of HTX-011-19 (a long acting formulation of 5% bupivacaine and 0.15% meloxicam) and HTX-011-49 (a long acting formulation of 2.5% bupivacaine and 0.075% meloxicam) after subcutaneous administration in healthy subjects. - HTX C2014-02
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject has signed the informed consent form prior to study participation.
- •2. Subject is a healthy male or female volunteer between 18 and 55 years old (extremes inclusive).
- •3. Subject has a body weight between 55 kg and 100 kg and a BMI between 18 and 30 kg/m2 (extremes inclusive).
- •4. Subject can stay in study center for 6 days and return to study center for 2 consecutive days thereafter, and again on Day 12 (± 2 days).
- •5. Subject has the ability to lie in a semi-recumbent position for at least 1.5 hours.
- •6. Subject is appropriate for the study in the judgment of the investigator, based on physical examination, laboratory tests, and subject*s interview.
- •7. Subject has a skin-type I or II (Fitzpatrick).
- •8. Subject is willing to use adequate contraception from the time of dosing until 90 days after the follow-up visit. o For male subjects: subjects with female partner of childbearing potential must agree to use a highly effective form of birth control, which entails the use of oral, injected or implanted hormonal methods of contraception or intra-uterine device/system by the female partner, in combination with a barrier method (e.g. condom, diaphragm, cervical cap with spermicide) during the study and for 90 days after discontinuation of treatment. Furthermore male subjects must agree not to donate sperm during participation in the trial and for 90 days after discontinuation of treatment; For female subjects: confirmed post-menopausal women, or female subjects agreeing to use a highly effective form of birth control, which entails the use of oral, injected or implanted hormonal methods of contraception or intra-uterine device/system in combination with a barrier method (e.g. condom, diaphragm, cervical cap with spermicide) during the study and for 90 days after discontinuation of treatment
排除标准
- •1. Subject has a medical history of allergies including hypersensitivity against drug or clinically significant allergies, incl. asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- •2. Subject has clinically significant abnormalities of hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, cardiovascular system, cancer or has a history of cancer.
- •3. Subject has an abnormal laboratory result judged by the investigator as being clinically significant.
- •4. Subject has a positive urinary drug screen (incl. amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamine, morphine, phencyclidine, and tricyclic antidepressants).
- •5. Subject has a positive test for HIV antibody, HBsAg, or HCV antibody.
- •6. Subject has a QTc (Bazet) prolongation greater than or equal to 450 ms, or has significant electrocardiogram (ECG) abnormalities.
- •7. Subject is a heavy smoker (> 10 cigarettes or equivalents per day).
- •8. Subject is unwilling or unable to refrain from smoking while in the clinical research unit.
- •9. Subject has tattoos on the skin areas to be treated.
- •10. Subject has a history of hypersensitivity reactions for any IMP constituent including bupivacaine and other amide-type local anesthetics, and meloxicam.
- •11. Subject has a supine SBP < 90mmHg or supine SBP > 140mmHg, or supine DBP < 55mmHg or supine DBP > 90mmHg, or Pulse rate > 100 per/min.
- •12. Subject has used any prescription drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days prior to Day 1 of any study period.
- •13. Subject participated in a previous clinical trial with administered IMP within 90 days prior to Day 1 of the first study period.
- •14. Subject is a heavy alcohol consumer (alcohol > 23 units/week) or cannot stop drinking while in the clinical research unit.
- •15. Subject lost a volume of blood, including through blood donation, of more than 400 mL within 8 weeks prior to Day 1.
- •16. Subject is unwilling or unable to adhere to any specific protocol restriction as mentioned in Section 8.3.3 of the protocol.
- •17. For females: Subject is currently pregnant, breast feeding, or disagrees to avoid getting pregnant during the clinical study.
- •18. Subject is legally incapable or has limited legal capacity at screening.
研究者
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