Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin 5 mg / Pioglitazone 30 mg Compared With Its Mono-components in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Replicate Design Study With Two Treatments in Four Crossover Periods)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- AUC0-72 of Linagliptin
Study Overview
Brief Summary
The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1 Linagliptin/Pioglitazone (Test)
Fixed-Dose-Combination-Tablet, oral administration with 240 mL water
Intervention: Linagliptin/Pioglitazone (Drug)
2 Linagliptin + Pioglitazone (Ref)
Tablets, oral administration with 240 mL water for each treatment
Intervention: Linagliptin + Pioglitazone (Drug)
3 Linagliptin/Pioglitazone (Test)
Fixed-Dose-Combination-Tablet, oral administration with 240 mL water
Intervention: Linagliptin/Pioglitazone (Drug)
4 Linagliptin + Pioglitazone (Ref)
Tablets, oral administration with 240 mL water for each treatment
Intervention: Linagliptin + Pioglitazone (Drug)
Outcomes
Primary Outcomes
AUC0-72 of Linagliptin
Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours
Cmax of Linagliptin
Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.
AUC0-tz of Pioglitazone
Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point
Cmax of Pioglitazone
Time Frame: 0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)
Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.
Secondary Outcomes
- AUC0-tz for Linagliptin(0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours))
- AUC0-∞ of Linagliptin(0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours))
- AUC0-∞ of Pioglitazone(0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours))
- Tmax for Linagliptin(0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours))
- Tmax for Pioglitazone(0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours))