Bioequivalence of Solid/Crushed/Dissolved Forms of Biktarvy® (SOLUBIC)
Healthy Volunteers
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers aged between 18 and 55 years old, confirmed as being in good health by an attending physician based on a medical evaluation that includes medical history, taking vital signs, a physical examination, clinical laboratory tests and an ECG.
- Subject does not present any intolerance or anterior skin rashes under the study drugs (TAF, FTC, BIC).
- Subject has a body mass index of between 18 and 30 kg/m2, inclusive.
- Subject's test results are negative for HIV and Hepatitis B and C.
- Subject's veins are in good condition.
- Non-smoking subject who has not consumed nicotine or products containing nicotine for 90 days before taking the first treatment in the study.
- Participant is part of a social security scheme.
- Subject is able and willing to sign the informed consent form before the preliminary evaluations.
Exclusion Criteria:
- Subject's creatinine clearance is below 50 mL/min.
- Pregnant or breastfeeding women.
- Women of reproductive age without adequate contraception, such as: contraceptive pill, hysterectomy, sterilisation, intra-uterine device (coil), total abstinence, dual methods of contraception or two years after menopause. Women must agree to take precautions to avoid becoming pregnant for the duration of the study.
- Men in a relationship without adequate contraception.
- Subject taking any treatment (during the two weeks before Day 1) that could interfere with the study medications (TAF, FTC, BIC): rifampicin, St. John's wort, antacids containing magnesium and/or aluminium, iron-based drugs, carbamazepine, ciclosporin, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, sucralfate, macrolides, verapamil, dronedarone, metformin, antimycobacterial medications, antifungal medications, supplements containing calcium, sertraline or methadone.
- Subject with a relevant medical history or current illnesses that are likely to interfere with the absorption, distribution, metabolism or excretion of the medication.
- Subjects with liver enzyme rates (ALAT, ASAT) of alkaline phosphatase and bilirubin higher than or equal to 1.5 times the upper normal value.
- Albumin <35 g/L, serum total protein <65 g/L
- Subject has a QTc <450 ms
- Subject with a pre-existing condition, a surgical sequela or a medical device that disrupts normal gastro-intestinal anatomy or motility or liver and/or kidney function, damaging the absorption, metabolism and/or excretion of the study drugs. A subject who has a medical history of a cholecystectomy, peptic ulcers, inflammatory intestinal diseases or pancreatitis must be excluded.
- Subject has a history of drug, alcohol or solvent abuse or currently abuses such substances.
- Subject is under guardianship or trusteeship.
- Subject is unable to understand the nature and scope of the study and the required procedures.
- Subject who participated in a study with the medication in the 60 days before the first day.
Sites / Locations
- CHU de Caen
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
BIKTARVY® ADMINISTRATION DISSOLVED IN WATER
BIKTARVY® ADMINISTRATION CRUSHED
BIKTARVY® ADMINISTRATION SOLID
BIKTARVY® route in healthy volunteers: dissolved in water in Pharmacokinetics study protocol Compare the pharmacokinetic (PK) of dissolved in water versus crushed and solid form of BIKTARVY® in the same healthy volunteer, to determine if there is a PK equivalence between these three modes of administration of BIKTARVY®.
BIKTARVY® route in healthy volunteers: crushed in Pharmacokinetics study protocol Compare the pharmacokinetic (PK) of crushed versus dissolved in water and solid form of BIKTARVY® in the same healthy volunteer, to determine if there is a PK equivalence between these three modes of administration of BIKTARVY®.
BIKTARVY® route in healthy volunteers: solid tablet in Pharmacokinetics study protocol Compare the pharmacokinetic (PK) of solid form of BIKTARVY® versus dissolved in water and crushed in the same healthy volunteer, to determine if there is a PK equivalence between these three modes of administration of BIKTARVY®.