Phase 1
Completed N=28
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
Healthy Volunteers
Source: ClinicalTrials.gov NCT02014272 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) — 85020; 90030; 16220; 16120 (nanogram*hour) per milliliter (ng*h/mL)
Summary
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
85020; 90030; 16220; 16120 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
13670; 15000; 6080; 5577 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
86670; 91340; 16680; 17390 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
3.608; 3.572; 2.776; 3.000 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
1.67; 1.67; 0.500; 0.500 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a signed and dated informed consent document and is willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), positive Hepatitis B surface antigen or HIV serology results;
- Pregnant or nursing female;
- History or active tuberculosis;
- Participated in investigational drug studies within 3 months;
- Used prescription or nonprescription drugs within 7 days or 5 half-lives.
Data sourced from ClinicalTrials.gov (NCT02014272). 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.