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
Verified date | June 2019 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Non-governmental healthcare Institution Road Clinical Hospital at the station Yaroslavl JSC Russian Railways | Yaroslavl |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Russian Federation,
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 |
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