Trials Sponsors Conditions Drugs Pricing

Conditions

Pharmacokinetic of Tenofovir in Healthy Subjects

Outcome Measures

Primary Outcomes (1)

Pharmacokinetic parameters
Area under the plasma concentration (AUC), peak concentration (Cmax), time to reach peak concentration (Tmax), elimination half-life (T1/2), total
Plasma sample: 0, 0.17, 0.33, 0.67, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post dose

Secondary Outcomes (1)

Adverse events and incidences
Within 1 hour before dosing, and 0.67, 12, 24, 36, 48 and 72 hours post dose

Study Arms (2)

Viproof Film Coated Tablets 300mg

EXPERIMENTAL

Dosage form：Film-coated tablet Strength： 300 mg/tablet Dose：300 mg (one tablet, single oral dose)

Drug: Tenofovir Disoproxil Fumarate 300 MG

Viread Tablets

ACTIVE COMPARATOR

Dosage form：Film-coated tablet Strength： 300 mg/tablet Dose：300 mg (one tablet, single oral dose)

Drug: Tenofovir Disoproxil Fumarate 300 MG

Interventions

Tenofovir Disoproxil Fumarate 300 MGDrug

One tablet of Viproof Film Coated Tablets or Viread Tablets will be orally administrated with 240 mL of water in the morning.

Viproof Film Coated Tablets 300mgViread Tablets

Eligibility Criteria

Age20 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy adult male or female subjects between 20-45 years of age.
Body weight within 80-120% of ideal body weight.

Sponsors & Collaborators

Taichung Veterans General Hospital
Othercollaborator
Yung Shin Pharm. Ind. Co., Ltd.
Industrylead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 17, 2020

Study Start

April 22, 2019

Actual (reported)

Pharmacokinetics of Two Formulation of Tenofovir Disoproxil Fumarate

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Viproof Film Coated Tablets 300mg

Viread Tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Viproof Film Coated Tablets 300mg

Viread Tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations