Phase 1
Completed N=72
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
Source: ClinicalTrials.gov NCT03501277 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone — 165.3; 154.9; 162.3; 157.4 nanogram per milliliter (ng/ml) — p=0.014
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone |
165.3; 154.9; 162.3; 157.4; 678.3; 706.5 | 0.014 sig |
| PRIMARY AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone |
2197.3; 2163.4; 2194.7; 2195.0; 5726.0; 5471.9 | 0.081 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03501277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.