NCT03501277

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

A Randomized, Open-Label, Single-Dose, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin (25 mg) and Pioglitazone (15 and 30 mg) When Administered as Individual Tablets and as Fixed-Dose Combination Tablets to Healthy Russian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The drug being tested in this study are called Incresync (SYR-322-4833 BL), alogliptin, and pioglitazone. This study will assess the bioequivalence, pharmacokinetics (PK), and safety of alogliptin and pioglitazone administered as individual tablets and as the FDC tablet product in healthy volunteers. The study will enroll approximately 72 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment sequences to receive one of the following treatments: * Regimen A: SYR-322-4833 BL (25 mg + 15 mg) * Regimen B: Alogliptin 25 mg + pioglitazone 15 mg * Regimen C: SYR-322-4833 BL (25 mg + 30 mg) * Regimen D: Alogliptin 25 mg + pioglitazone 30 mg All participants will be asked to take single dose of study medication on Day 1 of each intervention period. This single center trial will be conducted in Russia. The overall time to participate in this study is 66 days. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after their last dose of drug for a follow-up assessment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Alogliptin	Alogliptin tablets.
DRUG	Pioglitazone	Pioglitazone tablets.
DRUG	SYR-322-4833 BL	SYR-322-4833 BL FDC tablets.

Timeline

• Start date: 2018-05-26
• Primary completion: 2018-07-11
• Completion: 2018-07-11
• First posted: 2018-04-18
• Last updated: 2019-08-08
• Results posted: 2019-08-08

Locations

1 site across 1 country: Russia

Regulatory

• FDA-regulated drug study