NCT01358344CompletedPhase 1
A Study to Determine the Bioequivalence of SCH 530348 2.5 mg Tablets Containing a High and Low Percentage of Drug as the Free Base Within the Range Used in the Pivotal Phase 3 Efficacy and Safety Trials. (Protocol No. P06558)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 173
- Primary Endpoint
- Maximal plasma concentration (Cmax) of SCH 530348
Study Overview
Brief Summary
The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding
- •History of coagulation disorder(s), thrombocytopenia, bleeding tendency, ulcers, or gastrointestinal bleeding
- •History of cardiac abnormalities including clinically relevant ECGs, frequent palpitations or syncopal episodes
- •Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug
- •History of any infectious disease within 4 weeks prior to drug administration
- •Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- •Positive screen for drugs with a high potential for abuse
- •History of alcohol or drug abuse in the past 2 years
- •Blood donation in the past 60 days
- •Previous treatment with SCH 530348
- •Currently participating in another clinical study or has participated in a clinical study within 30 days
- •Demonstrated allergic reactions
- •Smokes more than 10 cigarettes or equivalent tobacco use per day
- •History of malignancy
- •Has received any protocol-defined treatment which could interfere with ability to participate in the trial
Arms & Interventions
Standard Percentage
Experimental
Intervention: Pantoprazole (Drug)
Standard Percentage
Experimental
Intervention: SCH 530348 (standard percentage) (Drug)
High Percentage
Experimental
Intervention: Pantoprazole (Drug)
High Percentage
Experimental
Intervention: SCH 530348 (high percentage) (Drug)
Outcomes
Primary Outcomes
Maximal plasma concentration (Cmax) of SCH 530348
Time Frame: Up to 72 hours after SCH 530348 dose on Day 5
Area under the plasma concentration-time curve from 0 to 72 hours (AUC[0-72h]) of SCH 530348
Time Frame: Up to 72 hours after SCH 530348 dose on Day 5
Secondary Outcomes
- Number of participants experiencing clinical and laboratory adverse events (AEs)(Up to 2 weeks after last dose)
Investigators
Similar Trials
Completed
Phase 1
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the BodyHealthyNCT06393127Boehringer Ingelheim64
Completed
Phase 1
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy SubjectsType 2 Diabetes MellitusNCT01068730AstraZeneca28
Completed
Phase 1
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)Diabetes MellitusNCT01192139AstraZeneca30
Completed
Phase 1
A Study in Healthy People to Compare How 2 Different Low Dose Formulations of BI 1015550 Are Taken up in the BodyHealthyNCT06408870Boehringer Ingelheim64
Completed
Phase 1
r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence TrialGrowth FailureGrowth Hormone DeficiencyNCT01034735EMD Serono30