PMID- 36047047
OWN - NLM
STAT- MEDLINE
DCOM- 20230302
LR  - 20230321
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Linking)
VI  - 12
IP  - 3
DP  - 2023 Mar
TI  - Pharmacokinetics, Bioequivalence, and Safety of 2 Formulations of 
      Hydroxychloroquine Tablets in Healthy Chinese Volunteers Under Fasting and Fed 
      Conditions.
PG  - 273-278
LID - 10.1002/cpdd.1166 [doi]
AB  - The purpose of this trial was to evaluate the pharmacokinetics (PK), 
      bioequivalence (BE), and safety of 2 preparations of hydroxychloroquine (200-mg 
      tablet) under fasting and fed conditions. A total of 180 subjects (fasting 
      condition: n = 80; fed condition: n = 100) were randomly enrolled in this 
      randomized, open, single-dose, single-cycle parallel phase Ⅰ clinical study. 
      Under the 2 conditions, the subjects were randomly administered the test (T) or 
      reference (R) tablet, both at a dose of 200 mg (1 tablet). Liquid 
      chromatography-tandem mass spectrometry was used to determine the concentration 
      of hydroxychloroquine in healthy subjects after oral administration of the T or R 
      preparation to evaluate the PK characteristics. In this trial, the T and R 
      preparations of hydroxychloroquine were bioequivalent under both conditions 
      within the range of 80%-125%. No serious adverse events (SAEs) were found in the 
      safety assessments for either condition, and all adverse events (AEs) were mild, 
      except for 2 moderate AEs in the fed condition, indicating good safety.
CI  - (c) 2022, The American College of Clinical Pharmacology.
FAU - Luo, Hong-Yu
AU  - Luo HY
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
FAU - Long, Hui-Zhi
AU  - Long HZ
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
FAU - Zhou, Zi-Wei
AU  - Zhou ZW
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
FAU - Xu, Shuo-Guo
AU  - Xu SG
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
FAU - Li, Feng-Jiao
AU  - Li FJ
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
FAU - Cheng, Yan
AU  - Cheng Y
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
FAU - Wen, Dan-Dan
AU  - Wen DD
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
FAU - Deng, Ping
AU  - Deng P
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
FAU - Gao, Li-Chen
AU  - Gao LC
AD  - School of Pharmacy, Department of Pharmacy, Phase Ⅰ Clinical Trial Centre, 
      Changsha Central Hospital Affiliated to University of South China, University of 
      South China, Hengyang, Hunan, China.
LA  - eng
GR  - 2016SK2066/Science and Technology Key Program of Hunan Province Grants/
GR  - 201940/WT_/Wellcome Trust/United Kingdom
GR  - 20201904/Science and Technology Key Program of Hunan Provincial Health Committee/
GR  - 2021JJ30753/Natural Science Foundation of Hunan Province/
GR  - YNKY202205/Changsha Central Hospital affiliated with the University of South 
      China Foundation of key Program/
GR  - 225 Program/Hunan Province Foundation of High-Level Health Talent/
GR  - 201940/WT_/Wellcome Trust/United Kingdom
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220901
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
RN  - 4QWG6N8QKH (Hydroxychloroquine)
RN  - 0 (Tablets)
SB  - IM
MH  - Humans
MH  - Area Under Curve
MH  - East Asian People
MH  - Fasting
MH  - Healthy Volunteers
MH  - *Hydroxychloroquine/pharmacokinetics
MH  - Tablets
MH  - *Therapeutic Equivalency
OTO - NOTNLM
OT  - bioequivalence
OT  - fasting
OT  - fed
OT  - hydroxychloroquine
OT  - pharmacokinetic
OT  - safety
EDAT- 2022/09/02 06:00
MHDA- 2023/03/03 06:00
CRDT- 2022/09/01 03:22
PHST- 2022/07/21 00:00 [received]
PHST- 2022/08/15 00:00 [accepted]
PHST- 2022/09/02 06:00 [pubmed]
PHST- 2023/03/03 06:00 [medline]
PHST- 2022/09/01 03:22 [entrez]
AID - 10.1002/cpdd.1166 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2023 Mar;12(3):273-278. doi: 10.1002/cpdd.1166. Epub 
      2022 Sep 1.