NCT02508168

Phase 1 Bioavailability Study of SYR-322MET

An Open-Label, Single-dose, Randomized, Crossover Study to Determine the Bioavailability and Bioequivalence of Alogliptin 12.5 mg and Metformin 1000 mg When Administered as Individual Tablets and as a Fixed-Dose Combination Tablet Vipdomet (Alogliptin FDC With Metformin) in Russian Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the relative bioavailability of alogliptin 12.5 milligram (mg) and immediate-release metformin 1000 mg when administered as individual tablets and as a fixed-dose combination (FDC) product.

Detailed description

The drug being tested in this study is called SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg FDC tablet). SYR-322MET is being tested to assess whether its pharmacokinetic properties (how it is processed by the body) are affected when administered as a FDC compared to administration of alogliptin and metformin alone. This study will look at lab results in people who take SYR-322MET. This crossover study will enroll approximately 24 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of two treatment sequences. All participants will receive both treatments over two periods; the order of receipt will be determined by the randomization code. All participants will receive the following study medications by the end of the study: * Alogliptin 12.5 mg + Metformin 1000 mg as individual tablets * SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg fixed-dose combination \[FDC\] tablet) This single center trial will be conducted in Russia. The overall time to participate in this study is up to 63 days. Participants will make multiple visits to the clinic including two 4-day periods of confinement to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Alogliptin	Alogliptin 12.5 mg tablets
DRUG	Metformin Hydrochloride	Metformin hydrochloride 1000 mg tablets
DRUG	SYR-322MET	SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-07-24
• Last updated: 2016-10-05