MedTrace Logo

Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State

NCT03705533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-12-27

No results posted yet for this study

Summary

This single center, randomized, single dose, full replicate, crossover comparative laboratory-blinded study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of telmisartan 80 mg tablets after oral administration under fasting conditions.

Conditions

  • Bioequivalence

Interventions

DRUG

Telmisartan

Telmisartan is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 80 mg of telmisartan.

DRUG

Micardis

Micardis is manufactured by Boehringer Ingelheim Ellas AE, Greece. Each tablet contains 80 mg of telmisartan.

Sponsors & Collaborators

  • Algorithme Pharma, An Altasciences Company

    collaborator UNKNOWN

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, MD · Altasciences Company Inc. (doing business as Algorithme Pharma)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2018-12-16
Completion
2018-12-19

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705533 on ClinicalTrials.gov