Healthy Volunteers Clinical Trial
— RHINE-4Official title:
A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon's Human Insulin R U-500 and Humulin® R U-500 (RHINE-4: Recombinant Human INsulin Equivalence-4)
Verified date | May 2023 |
Source | Biocon Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
Status | Completed |
Enrollment | 78 |
Est. completion date | December 12, 2022 |
Est. primary completion date | December 12, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Healthy male or post-menopausal female subjects. The post-menopausal state is defined as no menses for 12 months without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (= 25.8 IU/L). - Age between 18 and 55 years, both inclusive. - Body Mass Index (BMI) between 18.5 and 29.0 kg/m2, both inclusive. - Fasting plasma glucose concentration = 100 mg/dL. - Considered generally healthy upon completing the medical history and screening safety assessments, as judged by the Investigator. Exclusion Criteria: - Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related products. - Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation in this trial. - Systolic blood pressure < 90 mmHg or > 139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg after resting for at least 5 minutes in the supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable). - Pulse rate at rest outside the range of 50-90 beats per minute. |
Country | Name | City | State |
---|---|---|---|
Germany | Profil Institut für Stoffwechselforschung GmbH 9 | Neuss |
Lead Sponsor | Collaborator |
---|---|
Biocon Limited | Profil Institut für Stoffwechselforschung GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety endpoint: Number of subjects with Adverse Events (AEs) | Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate) | ||
Other | Safety endpoint: Number of subjects with Clinically significant changes in Physical examination | Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate) | ||
Other | Safety endpoint: Number of subjects with Clinically significant changes in Vital signs | Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate) | ||
Other | Safety endpoint: Local tolerability assessment / Injection site reactions | Number of subjects with Injection Site Reactions | Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate) | |
Other | Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters | Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate) | ||
Other | Safety endpoint: Number of subjects with clinically significant changes in ECG | Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate) | ||
Primary | Primary pharmacokinetics (PK) endpoint: area under the insulin concentration curve(AUCins).0-12h | Area under the insulin concentration curve | 0 to12 hours | |
Primary | Primary pharmacokinetics (PK) endpoint: maximum observed insulin concentration(Cins.max) | Maximum observed insulin concentration | NAP (Not Applicable) | |
Primary | Primary pharmacodynamics (PD) endpoint:area under the glucose infusion rate curve (AUCGIR)0-12h | Area under the glucose infusion rate curve | 0 to 12 hours | |
Primary | Primary pharmacodynamics (PD) endpoint:maximum observed glucose infusion rate (GIRmax) | Maximum observed glucose infusion rate | NAP (Not Applicable) | |
Secondary | Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-infinity | Area under the insulin concentration-time curve | 0 hours to 24 hours | |
Secondary | Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-24h | Area under the insulin concentration-time curve | 0 to 24 hours | |
Secondary | Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve (AUCins).12-24h | Area under the insulin concentration-time curve | 12 to 24 hours | |
Secondary | Secondary pharmacokinetics (PK) endpoint:time to maximum observed insulin concentration (tmax.ins) | Time to maximum observed insulin concentration | 0 to 24 hours | |
Secondary | Secondary pharmacokinetics (PK) endpoint:terminal elimination rate constant of insulin (?z) | Terminal elimination rate constant of insulin | 0 to 24 hours | |
Secondary | Secondary pharmacokinetics (PK) endpoint: terminal elimination half-life (t½) | Terminal elimination half-life calculated | 0 to 24 hours | |
Secondary | Secondary pharmacokinetics (PK) endpoint: time(t)50%-Insulin (INS)(early) | Time to half-maximum before Cmax | 0 to 24 hours | |
Secondary | Secondary pharmacokinetics (PK) endpoint: time(t) 50%-Insulin (INS)(late) | Time to half-maximum after Cmax | 0 to 24 hours | |
Secondary | Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).0-24h | Area under the glucose infusion rate curve | 0 to 24 hours | |
Secondary | Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h | Area under the glucose infusion rate curve | 12 to 24 hours | |
Secondary | Secondary pharmacodynamics (PD) endpoint: time to maximum glucose infusion rate(tmax.GIR) | Time to maximum glucose infusion rate | 0 to 24 hours | |
Secondary | Secondary pharmacodynamics (PD) endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early) | Time to half-maximum glucose infusion rate before GIRmax | 0 to 24 hours | |
Secondary | Secondary pharmacodynamics (PD) endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) | Time to half-maximum glucose infusion rate after GIRmax | 0 to 24 hours | |
Secondary | Secondary pharmacodynamics (PD) endpoint: Onset of action, time from trial product administration until plasma glucose concentration has decreased at least 5 mg/dL from baseline, | Time from trial product administration until plasma glucose concentration | 0 to 24 hours |
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