CompletedNCT03501277Updated Aug 8, 2019Results posted

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 Phase 1 interventional study of Alogliptin and Pioglitazone in Healthy Volunteers, sponsored by Takeda. Completed at 1 site in Russia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by Takeda · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Read the 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 studied

Healthy Volunteers

Keywords

Drug therapy

In context

Lead sponsor

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Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 72 participants (actual)

Study arms

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

DrugAlogliptin
Alogliptin tablets.
DrugPioglitazone
Pioglitazone tablets.
DrugSYR-322-4833 BL
SYR-322-4833 BL FDC tablets.
Also known as: Incresync

What researchers measure

Primary outcomes

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

Results

Posted Aug 8, 2019

Participant flow

Participants took part in the study at 1 investigative site in Russia from 26 May 2018 to 11 July 2018.

Intervention Period 1 (4 Days)

Participant flow — Intervention Period 1 (4 Days)
Milestone	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC
Started	18	18	18	18
Safety analysis set	18	18	17	17
Completed	18	18	17	17
Not completed	0	0	1	1
Withdrew: Other	0	0	1	0
Withdrew: Adverse event	0	0	0	1

Washout Period 1 (7 Days)

Participant flow — Washout Period 1 (7 Days)
Milestone	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC
Started	18	18	17	17
Completed	18	18	17	17
Not completed	0	0	0	0

Intervention Period 2 (4 Days)

Participant flow — Intervention Period 2 (4 Days)
Milestone	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC
Started	18	18	17	17
Completed	18	18	17	16
Not completed	0	0	0	1
Withdrew: Adverse event	0	0	0	1

Washout Period 2 (7 Days)

Participant flow — Washout Period 2 (7 Days)
Milestone	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC
Started	18	18	17	16
Completed	18	18	17	16
Not completed	0	0	0	0

Intervention Period 3 (4 Days)

Participant flow — Intervention Period 3 (4 Days)
Milestone	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC
Started	18	18	17	16
Completed	18	18	17	15
Not completed	0	0	0	1
Withdrew: Adverse event	0	0	0	1

Washout Period 3 (7 Days)

Participant flow — Washout Period 3 (7 Days)
Milestone	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC
Started	18	18	17	15
Completed	18	18	17	15
Not completed	0	0	0	0

Intervention Period 4 (4 Days)

Participant flow — Intervention Period 4 (4 Days)
Milestone	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC
Started	18	18	17	15
Completed	18	18	17	15
Not completed	0	0	0	0

Outcome measures

PrimaryCmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone

Time frame:: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Reported as:: Geometric mean · nanogram per milliliter (ng/ml)

Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone
nanogram per milliliter (ng/ml)	Regimen A	Regimen B	Regimen C	Regimen D
Alogliptin	165.3 ± 42.87	154.9 ± 44.71	162.3 ± 51.19	157.4 ± 44.24
Pioglitazone	678.3 ± 267.58	706.5 ± 254.12	1052.1 ± 478.13	1141.5 ± 509.78

Statistical analysis

Regimen A vs Regimen B · ANOVA · p = 0.014 · Least square mean (lsm) difference: 1.0706 · 90% CI 1.0230 to 1.1204
Regimen C vs Regimen D · ANOVA · p = 0.326 · Lsm difference: 1.0276 · 90% CI 0.9817 to 1.0757
Regimen A vs Regimen B · ANOVA · p = 0.405 · Lsm diiference: 0.9594 · 90% CI 0.8837 to 1.0415
Regimen C vs Regimen D · ANOVA · p = 0.124 · Lsm difference: 0.9257 · 90% CI 0.8523 to 1.0053

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

Time frame:: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Reported as:: Geometric mean · hour*nanogram per milliliter (h*ng/mL)

AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone
hournanogram per milliliter (hng/mL)	Regimen A	Regimen B	Regimen C	Regimen D
Alogliptin	2197.3 ± 340.92	2163.4 ± 362.83	2194.7 ± 379.27	2195.0 ± 379.80
Pioglitazone	5726.0 ± 1826.18	5471.9 ± 1766.76	10141.6 ± 3611.38	9907.6 ± 3495.57

Statistical analysis

Regimen A vs Regimen B · ANOVA · p = 0.081 · Lsm difference: 1.0157 · 90% CI 1.0009 to 1.0308
Regimen C vs Regimen D · ANOVA · p = 0.922 · Lsm difference: 1.0009 · 90% CI 0.9862 to 1.0158
Regimen A vs Regimen B · ANOVA · p = 0.066 · Lsm difference: 1.0486 · 90% CI 1.0051 to 1.0939
Regimen C vs Regimen D · ANOVA · p = 0.308 · Lsm difference: 1.0267 · 90% CI 0.9839 to 1.0714

Adverse events

Collected over Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug and no more than 14 days (approximately Day 35) or 30 days (approximately Day 51) for a serious adverse event after the last dose of study drug. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Regimen A	0/70 (0%)	0/70 (0%)	2/70 (2.9%)
Regimen B	0/69 (0%)	0/69 (0%)	1/69 (1.4%)
Regimen C	0/68 (0%)	0/68 (0%)	1/68 (1.5%)
Regimen D	0/70 (0%)	0/70 (0%)	2/70 (2.9%)

Most frequent other events

Most frequent other events
Event	Regimen A	Regimen B	Regimen C	Regimen D
HeadacheNervous system disorders	0/70	0/69	1/68	0/70
Allergic oedemaImmune system disorders	0/70	1/69	0/68	0/70
ContusionInjury, poisoning and procedural complications	1/70	0/69	0/68	0/70
Hand fractureInjury, poisoning and procedural complications	1/70	0/69	0/68	0/70
Blood creatinine increasedInvestigations	0/70	0/69	0/68	1/70
DizzinessNervous system disorders	1/70	0/69	0/68	1/70
SyncopeNervous system disorders	1/70	0/69	0/68	0/70
HypotensionVascular disorders	1/70	0/69	0/68	0/70

Baseline characteristics

The safety set included all randomized participants who received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC	Total
Mean	28.9 ± 7.95	23.9 ± 4.60	29.4 ± 8.46	27.5 ± 6.36	27.4 ± 7.18

Sex: Female, Male
Sex: Female, Male(Participants)	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC	Total
Female	9	7	8	9	33
Male	9	11	9	8	37

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC	Total
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	18	18	17	17	70
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	0	0	0
White	18	18	17	17	70
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC	Total
Russia	18	18	17	17	70

Weight
Weight(kilogram (kg))	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC	Total
Mean	68.77 ± 12.527	69.86 ± 12.409	75.06 ± 14.643	71.22 ± 15.894	71.17 ± 13.806

Body mass index (BMI)
Body mass index (BMI)(kilogram per square meter (kg/m^2))	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC	Total
Mean	24.21 ± 3.411	24.06 ± 2.959	24.78 ± 3.575	24.89 ± 3.628	24.48 ± 3.342

Height
Height(centimeter (cm))	Sequence I: ABCD	Sequence II: BCDA	Sequence III: CDAB	Sequence IV: DABC	Total
Mean	168.3 ± 8.56	169.9 ± 8.02	173.6 ± 10.22	168.4 ± 9.44	170.0 ± 9.14

Study locations

1 site

Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways
Yaroslavl, 150047, Russia

References and documents

Study documents

Study protocol · Jan 23, 2018
Statistical analysis plan · Jun 20, 2018

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03501277
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Apr 18, 2018
Start date: May 26, 2018
Primary completion: Jul 11, 2018
Completion: Jul 11, 2018
Results posted: Aug 8, 2019
Last update: Aug 8, 2019

Study contacts

Medical Director

study director · Takeda

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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