Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to compare the bioequivalence of two experimental fixed dose combination
      (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in
      healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will
      be open label, up to 3 periods design with a wash out period of at least 7 days between
      treatment periods. Subjects will be randomized to receive either single entities or
      formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16
      subjects who complete the first two treatment periods and consent to continue will receive a
      single dose of FDC formulation 1 tablet administered with a high fat meal for a third
      treatment period. In Part 2 of the study, subjects will be randomized to receive either
      single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods.
      Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat
      meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the
      last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the
      study and if Part 2 of the study is conducted, another 76 healthy subjects will be included.
      The total duration will be approximately 11 weeks.
    


Intervention name(s): Dolutegravir; Lamivudine; Dolutegravir + Lamivudine FDC Formulation 1; Dolutegravir + Lamivudine FDC Formulation 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.; Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.<br>3TC will be gray, diamond shaped tablet, engraved "GX EJ7" on one side and plain on the other side.; Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. &lt;br&gt;FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.; Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. &lt;br&gt;FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.
Intervention MeSH terms: Lamivudine; Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FDC; Lamivudine; Bio-equivalence; Dolutegravir; HIV