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Expert Opinion on Drug Metabolism & Toxicology Volume 17, 2021 - Issue 9
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Original research

Pharmacokinetic and pharmacodynamic evaluation of the new prolonged-release leuprorelin acetate microspheres for injection compared with Enantone® in healthy Chinese male volunteers

Huan Zhoua First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China;b School of Pharmacy, Bengbu Medical University, Bengbu, Anhui, China;c School of Public Foundation, Bengbu Medical University, Bengbu, Anhui, ChinaORCID Iconhttps://orcid.org/0000-0002-9396-8787View further author information
ORCID Icon,
Jing Xiea First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Xingyu Zhua First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China;b School of Pharmacy, Bengbu Medical University, Bengbu, Anhui, ChinaCorrespondence[email protected]
View further author information
,
Xiaoyi Lid Zhaoke Pharmaceutical (Hefei) Co., Ltd, Hefei, Anhui, ChinaView further author information
,
Xiaohui Yud Zhaoke Pharmaceutical (Hefei) Co., Ltd, Hefei, Anhui, ChinaView further author information
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Yong Zhangd Zhaoke Pharmaceutical (Hefei) Co., Ltd, Hefei, Anhui, ChinaView further author information
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Yue Sua First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China;c School of Public Foundation, Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Cuixia Hea First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China;b School of Pharmacy, Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Minhui Zhua First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China;b School of Pharmacy, Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Xiao li Lia First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
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Yuanyuan Liua First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Juan Chena First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
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Dongmei Chenga First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Mengmeng Chena First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Ying Wanga First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Qin Gea First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Ling Fana First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Ying Wanga First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
ZhongHuan Shaoa First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Bingyan Liua First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Rongfang Shana First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaView further author information
,
Xiangrong Daid Zhaoke Pharmaceutical (Hefei) Co., Ltd, Hefei, Anhui, ChinaCorrespondence[email protected]
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,
Hongju Wanga First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaCorrespondence[email protected]
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&
Huaxue Wanga First-in-Human Clinical Trial Wards in the National Institute of Clinical Drug Trials, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China;e Department of Critical Care Medicine, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, ChinaCorrespondence[email protected]
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Pages 1149-1156 | Received 17 Apr 2021, Accepted 23 Jun 2021, Published online: 10 Aug 2021

Figures & data

Figure 1. Flow diagram of this study

Figure 1. Flow diagram of this study

Table 1. Baseline characteristics (data set: ITT)

Figure 2. The mean drug concentration-time curve of leuprolide

Figure 2. The mean drug concentration-time curve of leuprolide

Table 2. The inferential analysis, the geometric mean ratio and the 90% CI of leuprolide pharmacokinetic parameters of the test group and the reference group (data set: PKS)

Figure 3. LH mean concentration-time curve

Figure 3. LH mean concentration-time curve

Figure 4. FSH mean concentration-time curve

Figure 4. FSH mean concentration-time curve

Figure 5. Testosterone mean drug concentration-time curve

Figure 5. Testosterone mean drug concentration-time curve

Table 3. Testosterone parameters (data set: ITT)

Table 4. Summary of adverse events (data set: SS)

Table 5. Summary of the relationship between TEAE and study drugs (data set: SS)

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