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 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: Alogliptin-1002U1111-1196-9223
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (2)

• Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Study Arms (4)

Sequence I: ABCD

EXPERIMENTAL

SYR-322-4833 BL (alogliptin 25 \[milligram\] mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D).

Drug: Alogliptin; Drug: Pioglitazone; Drug: SYR-322-4833 BL

Sequence II: BCDA

EXPERIMENTAL

Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A).

Drug: Alogliptin; Drug: Pioglitazone; Drug: SYR-322-4833 BL

Sequence III: CDAB

EXPERIMENTAL

SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B).

Drug: Alogliptin; Drug: Pioglitazone; Drug: SYR-322-4833 BL

Sequence IV: DABC

EXPERIMENTAL

Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C).

Drug: Alogliptin; Drug: Pioglitazone; Drug: SYR-322-4833 BL

Interventions

Alogliptin DRUG

Alogliptin tablets.

Sequence I: ABCD; Sequence II: BCDA; Sequence III: CDAB; Sequence IV: DABC

Pioglitazone DRUG

Pioglitazone tablets.

Sequence I: ABCD; Sequence II: BCDA; Sequence III: CDAB; Sequence IV: DABC

SYR-322-4833 BL DRUG

SYR-322-4833 BL FDC tablets.

Also known as: Incresync

Sequence I: ABCD; Sequence II: BCDA; Sequence III: CDAB; Sequence IV: DABC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is a healthy male or female.
• Has an estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 90 milliliter per minute (mL/min).
• Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening.

You may not qualify if:

• Has participated in a clinical study within 3 months prior to Check-in (Day-1).
• Has a fasting blood glucose level lower than 3.88 millimole per liter (mmol/L).
• Has received alogliptin or pioglitazone in a previous clinical study or as a therapeutic agent within 90 days prior to Check-in (Day-1).
• Experienced acute infectious diseases within 4 weeks prior to Screening.
• Has a positive urine drug result for super potent substances and drugs of abuse (defined as any illicit drug use) or positive alcohol breath test at Screening or Check-in (Day -1).
• Consumes over 10 drinks weekly (1 drink is equivalent to 0.5 liters of beer, 200 milliliter (mL) of dry wine or 50 mL of ardent spirits) or has a history of alcoholism, drug and/or substance abuse.
• Has a non-standard diet (example, vegetarian or vegan) or lifestyle (including night time work, extreme physical activity such as weights lifting), which may interfere with the trial.
• Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).
• Has poor peripheral venous access.
• Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1 of Period 1.
• Has consumed caffeine or xanthine-containing food or drinks within 72 hours prior to Check-in (Day -1).
• Has dehydration due to vomiting, diarrhea, or any other reason within 24 hours prior to study start.
• Has drug intolerance.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways

Yaroslavl, 150047, Russia

Location

MeSH Terms

Interventions

alogliptin; Pioglitazone

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 18, 2018
• Study Start: May 26, 2018
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2018
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-06

Locations

RU (1)