Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone
timeFrame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
measure: AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone
timeFrame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Yaroslavl
country: Russian Federation
facility: Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: