Yung Shin Pharm Ind Kunshan Co. Ltd.

主要研究目的 评价中国健康成年受试者空腹及餐后条件下单次单剂量口服盐酸米诺环素胶囊受试制剂[规格：100mg（按C23H27N3O7计），申办者：德全药品（江苏）股份有限公司]和参比制剂[商品名：ミノマイシン®（MINOMYCIN®），规格：100mg（按C23H27N3O7计），持证商：Pfizer Japan Inc.]后的药代动力学特点和生物等效性。 次要研究目的 研究盐酸米诺环素胶囊受试制剂[规格：100mg（按C23H27N3O7计）]和参比制剂[商品名：ミノマイシン®（MINOMYCIN®），规格：100mg（按C23H27N3O7计）]在中国健康成年受试者中的安全性。

Facial aging is a complex process characterized by skin atrophy, subcutaneous fat loss, and alterations in bone structure. The loss of volume, primarily due to bone resorption and loss of adjacent fat volume from different facial regions, leads to soft tissue flattening. Hyaluronic acid (HA) is a widely used biomaterial in clinical practice, known for its excellent tissue compatibility, low risk, and safety. Previous research and clinical practice have demonstrated that HA for facial lifting can help restore facial fullness, elasticity, and promote a more youthful appearance. Dermatologist previously utilized the supra-periosteum lift technique in high molecular weight hyaluronic acid injection. It was found that the material properties of high molecular weight hyaluronic acid not only made it suitable for filling but also provided lifting support, resulting in improvements in cheek fullness and facial aging. However, there has been no detailed quantitative study on the efficacy of high molecular weight hyaluronic acid for facial lifting.
To further investigate this effect, the investigators plan to conduct a prospective, open-label clinical trial. The investigators will recruit 25 adult and use an 8-point supra-periosteum facial lifting technique to inject high molecular weight hyaluronic acid. Assessments will be conducted preoperatively, postoperatively, and 4 weeks, 12 weeks and 24 weeks postoperatively to analyze the treatment efficacy. The eight injection points will be located at the brow peak, brow tail, pterion, lateral canthus, zygomatic ligament, mid-cheek, nasolabial fold, and mentalis. The investigators will use evaluation forms with four angles and six lengths, as well as the Global Aesthetic Improvement Scale, to quantify the degree of improvement in facial aging. Additionally, The investigators will use a satisfaction survey to understand subjects' perceptions of postoperative lifting effects and overall improvement satisfaction. The investigators hypothesized this study to improve facial aging in Asian patients and provide long-lasting effects.

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定德全药品(江苏)股份有限公司持证生产的盐酸多西环素片给药后血浆中的多西环素在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以PfizerJapanInc.持证生产的盐酸多西环素片[商品名:Vibramycin，规格:100mg(按C22H24NO8计)]为参比，评价制剂间的生物等效性，并观察盐酸多西环素片在中国健康受试者中的安全性。