Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2023/03/050853
CTRI/2023/03/050853
Completed
未知

A pilot randomized, double-blind, placebo-controlled, parallel-group clinical study to evaluate the safety and tolerability of BioPB-01 in healthy adults

Vedic Lifesciences Pvt Ltd0 sites64 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Vedic Lifesciences Pvt Ltd
Enrollment
64
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
September 12, 2023
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Participants who are 25 to 55 years of age (inclusive) at the time of signing the informed consent form.
  • •2\. Participants having good general health (no active or uncontrolled diseases, infections, or conditions).
  • •3\. BMI within the range of 24\.9 to 34\.9 kg/m2 (inclusive).
  • •4\. Random blood glucose level \<140 mg/dL.
  • •5\. Concurrent metformin use is acceptable for indications other than diabetes. (However, the subject and investigator must not change metformin dosing during the three weeks of the study).
  • •6\. Non\-pregnant and non\-lactating females of childbearing potential who agree to use adequate contraception/sexual abstinence throughout the study period.
  • •7\. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study\-related procedures.
  • •8\. Individuals with access to a digital device to fill out the questionnaires.

Exclusion Criteria

  • •1\. Participant has a history of uncontrolled hypertension (i.e., \=150 mmHg systolic and/or \=110 mmHg diastolic).
  • •2\. Participant with history of post\-prandial hypoglycemia (occurring 2\-5 hours after food intake) of unknown cause.
  • •3\. Abnormal thyroid\-stimulating hormone (TSH) levels ( \<0\.4 or \> 4\.2 µIU/ml).
  • •4\. Known case of Type 1 or 2 diabetes.
  • •5\. Participant has a history of heart disease and/or cardiovascular disease, kidney disease (dialysis or renal failure), and/or hepatic impairment or disease.
  • •6\. Participant has a history of previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the year prior to screening, immune disorder (i.e., HIV/AIDS), or a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit.
  • •7\. Received a vaccine for COVID\-19 or any other vaccination in the 2 weeks prior to screening or planned during the study period, current COVID\-19 infections, or currently have the post COVID\-19 condition as defined by the World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS\-CoV\-2 infection, usually 3 months from the onset of COVID\-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
  • •8\. Have a known intolerance, sensitivity, or allergy to any of the study products, their ingredients, or any excipients used in the formulation.
  • •9\. Individuals who have a known history of diverticulitis.
  • •10\. Have a known intolerance, sensitivity, or allergy to milk or soy.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Study to define the optimal dose, to evaluate efficacy, safety and tolerability of self- administered subcutaneous diclofenac sodium 25-50-75mg/1ml in the treatment of an acute migraine attack with headache.Acute migraine attacks with headache.MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2017-004828-29-ITIBSA INSTITUT BIOCHIMIQUE SA128
Active, not recruiting
Phase 1
A pilot study of the use of metformin to reduce airway glucose in COPDChronic obstructive pulmonary diseaseMedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2018-001755-12-GBImperial College40
Active, not recruiting
Not Applicable
A pilot, randomized, double-blind, placebo-controlled, parallel group, multicentre, phase IIa study to determine the clinical safety/tolerability and exploratory efficacy of EHT 0202 (40 and 80 mg bid) as adjunctive therapy to acetylcholinesterase inhibitor over a 3-month period in ambulatory patients suffering from mild to moderate Alzheimer’s Disease (EHT 0202/002 protocol).
EUCTR2007-005549-39-FREXONHIT
Active, not recruiting
Not Applicable
A pilot, randomized, double-blind, placebo-controlled, crossoverstudy evaluating the efficacy and safety of Vardenafil versusplacebo administered 12, 18 and 24 hours prior to initiation ofsexual intercourse in subjects with ED.ERECTILE DISFUNCTIONMedDRA version: 6.1Level: PTClassification code 10061461
EUCTR2004-001549-13-ITGLAXO SMITHKLINE314
Completed
Not Applicable
A pilot, double-blind, randomised, placebo-controlled, exploratory study to investigate the safety and effect of calf intestinal Alkaline Phosphatase in patients with SEPsisSepsisInfections and InfestationsOther and unspecified infectious diseases
ISRCTN49482187AM-Pharma B.V. (Netherlands)32