- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Yaroslavl, Russian Federation, 150047
- Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
Alogliptin tablets.
Pioglitazone tablets.
SYR-322-4833 BL FDC tablets.
Other Names:
|
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).
|
Alogliptin tablets.
Pioglitazone tablets.
SYR-322-4833 BL FDC tablets.
Other Names:
|
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).
|
Alogliptin tablets.
Pioglitazone tablets.
SYR-322-4833 BL FDC tablets.
Other Names:
|
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).
|
Alogliptin tablets.
Pioglitazone tablets.
SYR-322-4833 BL FDC tablets.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
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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
|
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alogliptin-1002
- U1111-1196-9223 (OTHER: WHO)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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