A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-13

Study Completion Date

2025-04-15

Brief Summary

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A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sequence 1

Participants receive a single subcutaneous dose of the Test Drug(T), in the first period, followed by a washout period, and then a single subcutaneous dose of the Reference Drug(R) in the second period.

Group Type EXPERIMENTAL

Test Drug (Eutropin Catridge, 48IU/Cartridge)

Intervention Type DRUG

Liqid somatropin

Reference Drug (Eutropin, 4 IU/vial)

Intervention Type DRUG

Lyophilized somatropin

Sequence 2

Participants receive a single subcutaneous dose of the Reference Drug(R), in the first period, followed by a washout period, and then a single subcutaneous dose of the Test Drug(T) in the second period.

Group Type EXPERIMENTAL

Test Drug (Eutropin Catridge, 48IU/Cartridge)

Intervention Type DRUG

Liqid somatropin

Reference Drug (Eutropin, 4 IU/vial)

Intervention Type DRUG

Lyophilized somatropin

Interventions

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Test Drug (Eutropin Catridge, 48IU/Cartridge)

Liqid somatropin

Intervention Type DRUG

Reference Drug (Eutropin, 4 IU/vial)

Lyophilized somatropin

Intervention Type DRUG

Other Intervention Names

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T Test Drug R Reference Drug

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged 19 to 40years at screening.
* Voluntarily decide to participate and provide written informed consent.
* Able to receive the investigational product (IP) and pre-treatment drugs.
* Wiliing and able to comply with study requirements, including follow-up visits and blood/urine sampling.

Exclusion Criteria

* History of conditions contraindicating somatropin or pre-treatment drugs.
* Clinically significant medical history.
* Participation in another clinical trial and receipt of an investigational product within 80 days prior to the first IP administration.

Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes