Trial Condition(s):
Clinical Pharmacology
Bioequivalence study of BAY 77-1931 orally disintegrating tablet
Bayer Identifier:
18060
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration.
Inclusion Criteria
- Japanese healthy male adult volunteers (age, 20-45 years; BMI, 17.6-26.4 kg/m2)
Exclusion Criteria
- Regular use of medicines including Chinese herbal drugs - Clinically relevant findings in the physical examination - Subject who cannot take the study drug appropriately (e.g. weak biting force, insufficient salivary flow)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Fukuoka, Japan, 812-0025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Bioequivalence study of BAY 77-1931 orally disintegrating tablet – randomized, open-label, two-way crossover study to establish the bioequivalence between BAY 77-1931 orally disintegrating tablet 500 mg and Fosrenol chewable tablet 500 mg administered in Japanese healthy male adult subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each dayEach study drug was administered as multiple dose over 4-days under fed conditions with a washout interval of at least 14 days in between. Twenty four hours urine collection were repeated 5 times from morning on Day -2 to that on Day 4.Timeframe: 6 days
- Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing periodDuring lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6)Timeframe: baseline and over 3-days
Secondary Outcome
- Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3Timeframe: 1 day
- Plasma lanthanum concentrations (ng/mL)To measure plasma concentration of lanthanum, 6 mL of blood were collected before the breakfast on Day 1, Day 2, Day 3 and Day 4, and at 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours after administration on Day 4.Timeframe: 6 days
- Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)Timeframe: 6 days
- Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)Timeframe: 6 days
- Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)Timeframe: 6 days
- Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)Timeframe: 6 days
- Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6)Timeframe: 6 days
- Number of adverse events as a measure of safety and tolarabilityTimeframe: From Day 1, the day of the first study drug administration, in period 1 (day 1-3) to follow up, 7-10 days after the last study drug administration in period 2 (day 4 - 6)
- Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)Timeframe: 6 days
Additional Information
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