Dual Prevention Pill (DPP) / TELE
The proposed product is a fixed-dose combination (FDC) tablet of TDF / FTC / LNG / EE indicated for both the prevention of HIV and pregnancy. The product will be supplied as a 28-count blister compliance pack containing 21 tablets of the fixed-dose combination of TDF, FTC, LNG, and EE (a 3-week supply) plus 7 tablets of FTC and TDF (a 1-week supply).
Clinical – Bioequivalence Study
Delivery Route & Method:
Systemic - Pill/Tablet- Oral
Mechanism of Action:
Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate; Emtricitabine is a nucleoside analogue of cytidine. Progestogen-oestrogen combination acts by inhibiting ovulation.
- The Bill & Melinda Gates Foundation
- Children’s Investment Fund Foundation (CIFF)
- Emtricitabine (FTC)
- Ethinyl Estradiol (EE)
- Tenofovir Disoproxil Fumarate (TDF)