Journal of Bioequivalence & Bioavailability

The Government Pharmaceutical Organization, 75/1 Rama VI Road, Ratchathewi, Bangkok, Thailand

Publications

• Research Article   
  Bioequivalence and Pharmacokinetics of a Fixed-Dose Combination of Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate in Healthy Thai Volunteers
  Author(s): Wiwat Supasena, Ekawan Yoosakul, Mathus Sawpitiporn, Charinthon Seeduang, Suchada Rakphung, Anas Sunhem, Mariam Duereh, Jaturavit Vattanarongkup, Vipada Khaowroongrueng*, Lalinthip Saeaue, Busarat Karachot, Piengthong Narakorn, Porranee Puranajoti and Isariya Techatanawat
  
  A regimen of dolutegravir, lamivudine and tenofovir disoproxil fumarate has been approved to treat Human Immunodeficiency Virus (HIV) infection. To enhance patient adherence and accessibility to combined antiretroviral therapy, a fixed-dose combination formulation for this regimen had been developed. A comparative randomized, single dose, two-way crossover, open-label study was conducted in 52 healthy Thai volunteers to evaluate the bioequivalence and pharmacokinetics of the fixed-dose combination compared with those of separate tablets. Blood samples were collected through 72 hours post-dose. The concentrations of dolutegravir, lamivudine and tenofovir, an active metabolite of tenofovir disoproxil fumarate in the processed plasma samples were determined using two validated LC-MS/MS methods. The primary pharmacokinetic parameters were the area under the plasma concentration-time curve.. View more»
  

  DOI: 10.35248/0975-0851.23.15.518

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