Investigating the in vivo bioequivalence of Effavirenz/Emtricitabine/Tenofovir tablet

In vivo bioequivalence study of Effavirenz/Emtricitabine/Tenofovir (600/200/300) manufactured by Bakhtar Bioshimi Co. compared with innovator product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220211053992N29

Enrollment

Registered

2024-03-15

Start date

2024-04-19

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention 1: Intervention group: Intervention group will receive a single oral dose of test product (Effavirenz/Emtricitabine/Tenofovir tablet manufactured by Bakhtar Bioshimi Co.) in fasted state.

Eligibility

Sex/Gender

All

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease, liver and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: 0.5-72 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Valizadeh

Tabriz University of Medical Sciences

valizadehh@gmail.com+98 41 3334 8801

Outcome results