Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF)
      300 mg in Chinese subjects to support the registration of this compound in the People's
      Republic of China. This will be an open-label, single group, single and repeat dose study
      without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable
      measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after
      the single dose and at steady state. The duration of the study will be approximately 7 weeks
      from screening to follow-up.
    

Detailed description: 
      This will be an open-label, single group, single and repeat dose study with no placebo
      control in healthy Chinese subjects conducted at a single centre. The study will include a
      screening visit, single and repeat dose sessions and a follow-up contact.

      The screening visit will be conducted up to 28 days prior to the first dose of treatment
      period 1. Screening assessments will occur as indicated in the Time and Events Table.

      Subjects who meet the inclusion/exclusion criteria will be admitted to the study centre on
      Day -1 to undergo baseline procedures before the single dose session. Study medication will
      be administered the following morning (Day 1) for the single dose phase. Subjects will be
      required to fast for at least 8 h (overnight) prior to dosing until 4 h after dosing.
      Pharmacokinetic samples will be taken until Day 3.

      The repeat dose session will begin on Day 4. Subjects will receive a once daily dose of TDF
      300 mg in a fasted state each morning for 7 days. Subjects will be required to fast for at
      least 8 h (overnight) prior to dosing on Day 8 and Day 9, and for at least 8 h (overnight)
      prior to dosing until 4 h after dosing on Day 10. A trough pharmacokinetic sample will be
      collected before dosing on Day 8, Day 9 and a series of samples will be taken from Day 10 to
      Day 12.

      Subjects will remain in-house from the evening before dosing (Day -1) until after the final
      pharmacokinetic sample has been collected on Day 12 and the final safety assessment completed
      on Day 13. Then subjects will be discharged from the study centre at the Investigator's
      discretion.

      Subjects completing the dosing sessions will not be required to visit the study centre for a
      follow-up visit, unless the Investigator determines that it is necessary for safety or other
      reasons. All subjects will receive a follow-up contact by telephone or visit 7 days after the
      last dosing to collect any information on concomitant medication taken and AEs experienced
      since the last visit.

      The total duration of each subject's participation, from screening to follow-up contact, will
      be approximately 7 weeks.
    

Intervention name(s): TDF tablets
Intervention type(s): Drug
Intervention description(s): White, almond-shaped, film-coated tablets, one side with the markings "GILEAD" and "4331"
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy subjects; Tenofovir disoproxil fumarate; hepatitis; pharmacokinetics