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Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection, which is proposed for Assisted Reproductive Technology (ART). This is a randomized, open-label, two-period, two-crossover study to evaluate the safety and pharmacokinetics of recombinant human follicle stimulating hormone injection (LM001), compared with Gonal-F®, both given subcutaneously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A | Experimental | Gonal-F® |
|
| ARM B | Experimental | LM001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonal-F® | Drug | A single Subcutaneous injection, 225IU |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Maxmum observed serum concentration (Cmax) of LM001&Gonal-f® in healthy Chinese female subjects. | Maxmum observed serum concentration (Cmax) of LM001&Gonal-f® in healthy Chinese female subjects. | within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose. |
| Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T))for LM001&Gonal-f® in healthy Chinese female subjects. | Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T))for LM001&Gonal-f® in healthy Chinese female subjects. | within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time of Maxmum observed serum concentration (Tmax) of LM001&Gonal-f® in healthy Chinese female subjects. | Time of Maxmum observed serum concentration (Tmax) of LM001&Gonal-f® in healthy Chinese female subjects. | within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose. |
| Serum clearance(CL) of of LM001&Gonal-f® in healthy Chinese female subjects. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhua Ding, M.D. | Contact | 86-0431-88782168 | dingyanhua2003@126.com | |
| lei gao, M.D. | Contact | 398027192@qq.com |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
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| LM001 | Drug | A single Subcutaneous injection, 225IU |
|
|
Serum clearance(CL) of of LM001&Gonal-f® in healthy Chinese female subjects. |
| within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose. |
| Adjusted geometric means of area under the serum concentration-time curve from time zero extrapolated to infinite time(AUC(INF))for LM001&Gonal-f® in healthy Chinese female subjects. | Adjusted geometric means of area under the serum concentration-time curve from time zero extrapolated to infinite time(AUC(INF))for LM001&Gonal-f® in healthy Chinese female subjects. | within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose. |
| Serum Half-life(T-HALF)of LM001&Gonal-f® in healthy Chinese female subjects. | Serum Half-life(T-HALF)of LM001&Gonal-f® in healthy Chinese female subjects. | within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose. |
| Apparent volume of distribution(VD))of LM001&Gonal-f® in healthy Chinese female subjects. | Apparent volume of distribution(VD))of LM001&Gonal-f® in healthy Chinese female subjects. | within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose. |
| Expression of terminal clearance rate constant(λ z )of LM001&Gonal-f® in healthy Chinese female subjects. | Expression of terminal clearance rate constant(λ z )of LM001&Gonal-f® in healthy Chinese female subjects. | within 0.5h pre-dose, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose. |
| Number of Participants with Abnormal Labortory Values and/or Adverse Events that are realated to treatment(SAEs) and AEs of special interest. | Number of Participants with Abnormal Labortory Values and/or Adverse Events that are realated to treatment(SAEs) and AEs of special interest. | From screening to up to 16 days. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |