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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501277
• Other study ID #: Alogliptin-1002
• Secondary ID: U1111-1196-9223
• Status: Completed
• Phase: Phase 1
• Start date: May 26, 2018
• Est. completion date: July 11, 2018

Study information

• Verified date: June 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 11, 2018
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Is a healthy male or female.

2. Has an estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter per minute (mL/min).

3. 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.

Exclusion Criteria:

1. Has participated in a clinical study within 3 months prior to Check-in (Day-1).

2. Has a fasting blood glucose level lower than 3.88 millimole per liter (mmol/L).

3. Has received alogliptin or pioglitazone in a previous clinical study or as a therapeutic agent within 90 days prior to Check-in (Day-1).

4. Experienced acute infectious diseases within 4 weeks prior to Screening.

5. 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).

6. 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.

7. 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.

8. 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).

9. Has poor peripheral venous access.

10. 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.

11. Has consumed caffeine or xanthine-containing food or drinks within 72 hours prior to Check-in (Day -1).

12. Has dehydration due to vomiting, diarrhea, or any other reason within 24 hours prior to study start.

13. Has drug intolerance.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Alogliptin
Alogliptin tablets.
• Pioglitazone
Pioglitazone tablets.
• SYR-322-4833 BL
SYR-322-4833 BL FDC tablets.

Locations

Country	Name	City	State
Russian Federation	Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone		Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Primary	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