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A Study to Determine the Bioequivalence of Alogliptin and Pioglitazone When Administered as Individual Tablets and as Fixed-Dose Combination (FDC)-SYR-322-4833 BL Tablets to Healthy Russian Participants

NCT03501277 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-08-08

Study results available
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Summary

The purpose of this study is to assess the relative bioavailability and bioequivalence of 2 strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and pioglitazone tablets in healthy Russian participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Alogliptin

Alogliptin tablets.

DRUG

Pioglitazone

Pioglitazone tablets.

DRUG

SYR-322-4833 BL

SYR-322-4833 BL FDC tablets.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-05-26
Primary Completion
2018-07-11
Completion
2018-07-11
FDA Drug
Yes

Countries

  • Russia

Study Locations

More Related Trials

Entities

Companies

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 NCT03501277 on ClinicalTrials.gov