PMID- 34806331
OWN - NLM
STAT- MEDLINE
DCOM- 20220224
LR  - 20221207
IS  - 1742-7843 (Electronic)
IS  - 1742-7835 (Linking)
VI  - 130
IP  - 2
DP  - 2022 Feb
TI  - Pharmacokinetics, safety and bioequivalence of two formulations of progesterone 
      soft capsule in healthy Chinese postmenopausal females: Impacts of a high-fat 
      meal.
PG  - 268-276
LID - 10.1111/bcpt.13687 [doi]
AB  - Progesterone is an important natural hormone regulating ovulation and 
      menstruation. The present study aimed to investigate the pharmacokinetics and 
      safety of two formulations of progesterone in Chinese postmenopausal females 
      under fasting and fed conditions. The study adopted a single-dose, open-label, 
      randomized, three-period bioequivalence design. A total of 96 subjects were 
      enrolled and randomly assigned to the fasting cohort or fed cohort. A high-fat 
      meal (890 kcal) was used in the fed study. The reference-scaled average 
      bioequivalence method was used for bioequivalence evaluation. A high-fat meal led 
      to a 22-fold higher peak concentration (C(max) ) and a 7-fold higher area under 
      the curve (AUC) while time to reach C(max) and half-life was not significantly 
      affected. The concentration-time curve displayed double peaks suggesting the 
      existence of enterohepatic circulation. The test/reference geometric mean ratios 
      for C(max) and AUC under fasting and fed conditions are all within the range of 
      80% to 125%. All adverse events (AEs) that occurred during the trial were mild 
      and did not cause drop-out, though these AEs occurred more frequently under fed 
      state. In conclusion, the two formulations of progesterone are bioequivalent in 
      Chinese subjects under fasting and fed conditions. Drug label modification 
      regarding food effects needs further discussion.
CI  - (c) 2021 Nordic Association for the Publication of BCPT (former Nordic 
      Pharmacological Society). Published by John Wiley & Sons Ltd.
FAU - Qin, Huiling
AU  - Qin H
AD  - Department of Clinical Pharmacology, The Second Hospital of Anhui Medical 
      University, Hefei, China.
FAU - Zheng, Liang
AU  - Zheng L
AD  - Department of Clinical Pharmacology, The Second Hospital of Anhui Medical 
      University, Hefei, China.
FAU - Fang, Yuanyuan
AU  - Fang Y
AD  - Department of Obstetrics and Gynecology, The Second Hospital of Anhui Medical 
      University, Hefei, China.
FAU - Liu, Yueyue
AU  - Liu Y
AD  - Department of Clinical Pharmacology, The Second Hospital of Anhui Medical 
      University, Hefei, China.
FAU - Liu, Anding
AU  - Liu A
AD  - Department of Bioanalysis, Shanghai Xihua Scientific Co. Ltd., Shanghai, China.
FAU - Wu, Jinlian
AU  - Wu J
AD  - Research and Development Center, Zhejiang Medicine Co. Ltd., Zhejiang, China.
FAU - Zhu, Fengjia
AU  - Zhu F
AD  - Research and Development Center, Zhejiang Medicine Co. Ltd., Zhejiang, China.
FAU - Chen, Jing
AU  - Chen J
AD  - Research and Development Center, Zhejiang Medicine Co. Ltd., Zhejiang, China.
FAU - Fan, Yijun
AU  - Fan Y
AD  - Department of Obstetrics and Gynecology, The Second Hospital of Anhui Medical 
      University, Hefei, China.
FAU - Hu, Wei
AU  - Hu W
AUID- ORCID: 0000-0002-4809-7601
AD  - Department of Clinical Pharmacology, The Second Hospital of Anhui Medical 
      University, Hefei, China.
LA  - eng
GR  - Zhejiang Medicine Co. Ltd./
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20211202
PL  - England
TA  - Basic Clin Pharmacol Toxicol
JT  - Basic & clinical pharmacology & toxicology
JID - 101208422
RN  - 0 (Dietary Fats)
RN  - 0 (Progestins)
RN  - 4G7DS2Q64Y (Progesterone)
SB  - IM
MH  - Area Under Curve
MH  - Asian People
MH  - Cohort Studies
MH  - Dietary Fats
MH  - Fasting
MH  - Female
MH  - *Food-Drug Interactions
MH  - Half-Life
MH  - Humans
MH  - Middle Aged
MH  - *Postmenopause
MH  - Progesterone/*administration & dosage/adverse effects/pharmacokinetics
MH  - Progestins/*administration & dosage/adverse effects/pharmacokinetics
MH  - Therapeutic Equivalency
OTO - NOTNLM
OT  - bioequivalence
OT  - clinical trial
OT  - food effect
OT  - pharmacokinetics
OT  - progesterone
EDAT- 2021/11/23 06:00
MHDA- 2022/02/25 06:00
CRDT- 2021/11/22 07:22
PHST- 2021/11/05 00:00 [revised]
PHST- 2021/10/05 00:00 [received]
PHST- 2021/11/16 00:00 [accepted]
PHST- 2021/11/23 06:00 [pubmed]
PHST- 2022/02/25 06:00 [medline]
PHST- 2021/11/22 07:22 [entrez]
AID - 10.1111/bcpt.13687 [doi]
PST - ppublish
SO  - Basic Clin Pharmacol Toxicol. 2022 Feb;130(2):268-276. doi: 10.1111/bcpt.13687. 
      Epub 2021 Dec 2.