None listed
Conditions
Interventions
Intervention1: Active: Testosurge 500 mg capsules: 500 mg a capsule once daily in the evening around 08.00 pm., before a meal for 07 days during Period 1 and Period 2.
Control Intervention1: Placebo:
Sponsors
Indus Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult male volunteers aged 18 to 45 years (inclusive) with a weight of at least 50 kg and a Body Mass Index (BMI) between 18.50 and 30.00 kg/m² (inclusive). Volunteers must provide adequate evidence of their identity and demonstrate the capability and willingness to give informed written consent and adhere to study requirements. Participants must be assessed as healthy based on personal and medical history, general medical examination, and absence of significant disease as judged by the Principal Investigator (PI). Volunteers must have normal laboratory parameters (hematology, biochemistry, and serology) or have abnormalities deemed clinically insignificant, with tests conducted within 21 days prior to check-in for Period 1, as judged by the PI. Participants must test negative on a urine screen for drugs of abuse, including cannabinoids (CANNAB/Tetrahydrocannabinol-THC), amphetamines (AMP), barbiturates (BAR), cocaine (COC), benzodiazepines (BZO), and opioids (MOR/OPI). A negative breath alcohol test is required. Volunteers must be willing to use highly effective contraception consistently and correctly throughout the duration of the study.
Exclusion criteria
Exclusion criteria: History or presence of significant hematopoietic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological conditions, urinary retention, severe gastrointestinal disorders, dysphasia, myasthenia gravis, narrow-angle glaucoma, tachyarrhythmia, psychiatric diseases or disorders, diabetes mellitus, tuberculosis, systemic hypertension, or any medical disorder deemed significant by the Principal Investigator (PI). History of any major surgical procedure, depot injections or drug implants in the past 3 months, or a history of dialysis. History or presence of any medication for joint pain, inflammation, or kidney/urinary tract stones. Recent history of dehydration due to diarrhea, vomiting, or any other cause within 24 hours prior to check-in. History or presence of cancer. Difficulty in donating blood, personal or family history of muscular disorders, or any deformity affecting venous access for cannulation. Consumption of alcohol within 48 hours prior to check-in Day 01 or difficulty abstaining from alcohol during the study. Consumption of caffeine and/or xanthine products (e.g., coffee, tea, chocolate, caffeine-containing sodas) within 24 hours prior to check-in Day 01 for each period. Consumption of tobacco products and grapefruit or its juices within 48 hours prior to check-in for Period 1. History of allergies to vegetables and/or food substances or any manifestations suggestive of hypersensitivity reactions. Present or past use of medications that potentially modify the kinetics/dynamics of the study medications, or any other medication deemed clinically significant by the PI. Positive screening test result for any of the following: HIV, Hepatitis B, Hepatitis C, or VDRL. Intake of over-the-counter products, herbal medications, etc., within 7 days prior to check-in Day 01 for each period. Following an unusual diet (e.g., low sodium) for three weeks prior to check-in. History of hypersensitivity to study medications or related excipients in the formulation. History or presence of male sexual dysfunction and use of any medication within the last 30 days that may affect male sex hormones. Intake of supplements containing fenugreek. Intake of any natural or synthetic testosterone-boosting supplements. Any condition that, in the PI’s opinion, makes the subject unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Testosurge capsules on TT (ng/dL) levels by LC-MSTimepoint: 00.00 h (8:00 pm), 03.00 h (11:00 pm), 07.00 h (3:00 am), 10.00 h (6:00 am), 12.00 h (8:00 am), 15.00 h (11:00 am), 19.00 h (03:00 pm) and 22.00 h (06:00 pm) hours (± 15 minutes) after administration of IP on Day 01 and Day 07 in each period | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Testosurge capsules on serum SHBG (nmol/L) by Enzyme-linked immunosorbent assay (ELISA)Timepoint: 00.00 h (8:00 pm), 03.00 h (11:00 pm), 07.00 h (3:00 am), 10.00 h (6:00 am), 12.00 h (8:00 am), 15.00 h (11:00 am), 19.00 h (03:00 pm) and 22.00 h (06:00 pm) hours (± 15 minutes) after administration of IP on Day 01 and Day 07 in each period;To evaluate the efficacy of Testosurge capsules on the following parameters- • cFT (calculation) (ng/dL) • BT (calculation) (ng/dL) • Serum Albumin by Bromocresol Green method (g/dL) • Serum DHT by ELISA method (pg/ml) • Serum Estradiol by Chemiluminescence immunoassay (CLIA) (pg/ml) • Fasting Plasma Glucose by Colorimetry (mg/dL) • Fasting Serum Insulin by CLIA (microU/ml) • Plasma NAD+ by ELISA (ng/ml) • Plasma ATP by ELISA (ng/mL)Timepoint: 12.00 hour (08:00 AM) (± 15 minutes) (fasting blood samples) on day 02 and day 08 in each period. | — |
Countries
India
Contacts
Public ContactMrs Pallavi Deshpande
Indus Biotech Limited
Outcome results
None listed